OTC

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OTC References: Active Ingredients and Monographs
[29-Sept-2009]

[|Active ingredients by name]

[|Active Ingredients by category]

TERMINOLOGY UPDATES
[11-Feb-2009]

The following two new section headings are now acceptable in SPL documents:

OTC - ACTIVE INGREDIENT SECTION OTC - PURPOSE SECTION

The section headings and associated LOINC codes are located here: []

__Special Events__ None currently scheduled


 * Objective**: Address questions and concerns regarding SPL that affect the OTC industry.


 * Leader**: Vacant

Contact mhoward@chpa.org to join this group.


 * No Meeting/Teleconference schedule (calls scheduled as needed)**


 * Next meeting**:
 * TBD **

**2015 Call Summary Notes:** **2011 Call Summary Notes:** **2010 Call Summary Notes:** ||
 * Call Date || Summary Notes ||
 * 14 September 2015 || [[file:SPL OTC Sub-team 14 September 2015 091415.pdf]] ||
 * Call Date || Summary Notes ||
 * 12 September 2011 || [[file:SPL OTC Sub-team 12 September 2011 091411.pdf]] ||
 * 13 June 2011 || [[file:SPL OTC Sub-team 13 June 2011 061611.pdf]] ||
 * 11 April 2011 || [[file:SPL OTC Sub-team 11 April 2011 041411.pdf]] ||
 * 14 March 2011 || [[file:SPL OTC Sub-team 14 March 2011 031611.pdf]] ||
 * 14 February 2011 || [[file:SPL OTC Sub-team 14 February 2011 021811.pdf]] ||
 * Call Date || Summary Notes ||
 * 13 December 2010 || [[file:SPL OTC Sub-team 13 December 121510.pdf]] ||
 * 13 September 2010 || [[file:SPL OTC Sub-team 13 September 2010 091710.pdf]]
 * 12 July 2010 || [[file:SPL OTC Sub-team 12 July 2010 071310.pdf]] ||
 * 8 March 2010 || [[file:SPL OTC Sub-team 8 March 2010 031610.pdf]] ||


 * Training Materials** (not all inclusive)**:**


 * Training Materials from SPL R4 Overview & Training - Over-the-Counter Drug Products** (July 30, 2008):




 * Training Materials from SPL R4 Overview & Training - Over-the-Counter Drug Products** (June 26, 2009)




 * Training Materials from SPL R4 Overview & Training - Over-the Counter Drug Products** (July 8, 2009)




 * Training Materials from SPL R4 Training - Common Errors in SPL R4 Submissions** (July 8, 2009)




 * OTC SPL Template*** (Posted July 15, 2009)
 * Note**: Fictitious product label created by Pryia Samuel, CHPA



Instructions for viewing the file:

1. Copy zip file to location on computer.

2. Unzip the file

3. Open the SPL file


 * Vendor Presentations:**

**The vendor presentations are provided as educational opportunities only and do not reflect any endorsement or recommendation by the SPL OTC Sub-team, SPL Process Team, SPL Leadership Team, or the FDA**.


 * Additional Information:**

SPL Updates: Join FDA Data Standards Council's listserv. To join, select this link [|Sign up for email updates] on this web page: [].

FDA Electronic Submissions Gateway: []

Links to SPL R4 Electronic Drug Establishment Registration and Drug Listing documents: [] (see heading entitled "SPL Guidance and Supporting Documents.")

Question-and-Answer Document - Please view respective Discussion Pages for responses. New questions and issues to Marcia Howard, Paula Markert, and Devon Morgan for posting consideration.


 * Section headings and LOINC codes for OTC content**:
 * 50569-3 || OTC - ASK DOCTOR SECTION ||
 * 50568-5 || OTC - ASK DOCTOR/PHARMACIST SECTION ||
 * 50570-1 || OTC - DO NOT USE SECTION ||
 * 50565-1 || OTC - KEEP OUT OF REACH OF CHILDREN SECTION ||
 * 53414-9 || OTC - PREGNANCY OR BREAST FEEDING SECTION ||
 * 53413-1 || OTC - QUESTIONS SECTION ||
 * 50566-9 || OTC - STOP USE SECTION ||
 * 50567-7 || OTC - WHEN USING SECTION ||

Question
What LOINC code should be used for an Ingredients Section?

Answer
The LOINC code for DESCRIPTION can be used for the Ingredients Section in an OTC label.

See FDA SPL Resources Page for the complete list of [|section LOINC codes] and other terminologies.

Vendor Presentations and 2008, 2009 Call Summary docs