LOINCActive

LOINC Code 69403-4: FDA product label OTC medical device label

69403-4 is a LOINC code used to identify FDA product label OTC medical device label in laboratory and clinical observation data. You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges. LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component OTC medical device label. It is commonly used with the system or sample type ^FDA product label.

Reviewed by HealthAssure Clinical TeamUpdated 21 May 2026

What is this code?

LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component OTC medical device label. It is commonly used with the system or sample type ^FDA product label.

When is it used?

  • Used in lab systems, EHRs, and clinical data exchange.
  • May identify a test, observation, survey item, or clinical document request rather than a diagnosis.
  • Status: ACTIVE

What it does not mean

  • The code identifies the observation or test, not the actual result.

Key facts

  • FDA product label OTC medical device label
  • OTC medical device label
  • DOCUMENT.REGULATORY; FDA label; Narrative; Over-the-counter; Report

Where you may see this code

You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges.

Common synonyms

FDA product label OTC medical device labelFDA label OTC medical deviceOTC medical device labelDOCUMENT.REGULATORY-^FDA product labelNar

Frequently asked questions

Code details

Code69403-4
SystemLOINC
Display nameFDA product label OTC medical device label
DescriptionOTC medical device label
Short nameFDA label OTC medical device
ComponentOTC medical device label
Property-
Timing-
System (specimen)^FDA product label
ScaleNar
ClassDOCUMENT.REGULATORY
StatusACTIVE

Flags

BillableNo
Valid clinical useNo

Source

SourceLOINC
Version2.82
Releasemain
First released2.40
Last changed2.40

Part names

OTC medical device label-^FDA product labelNar

About this content

This page is prepared by HealthAssure's clinical team using official coding standards from LOINC. AI tools assist with drafting explanations, which are then reviewed and verified by healthcare professionals for accuracy. This content is for informational purposes and does not replace professional medical advice. Meet our team.

LOINC Code 69403-4 | HealthAssure