GUAIFENESIN - ODAAT 1200 MG

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: GUAIFENESIN - ODAAT 1200 MG
Generic name: GUAIFENESIN
Manufacturer: LODAAT LLC
Product type: HUMAN OTC DRUG
SPL set ID: f61d3ae0-11eb-2a82-e053-2995a90a95da
SPL ID: f61d3ae0-11ec-2a82-e053-2995a90a95da
Version: 1
Effective date: 2023-03-04
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:23:47

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	213420	derived:openfda.application_number
application number		ANDA213420	openfda.application_number
brand name		GUAIFENESIN - ODAAT 1200 MG	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		LODAAT LLC	openfda.manufacturer_name
ndc	package	83139-175-01	openfda.package_ndc
ndc	product	83139-175	openfda.product_ndc
ndc11	package	83139017501	derived:openfda.package_ndc
rxcui		310621	openfda.rxcui
spl id		f61d3ae0-11ec-2a82-e053-2995a90a95da	id
spl set id		f61d3ae0-11eb-2a82-e053-2995a90a95da	set_id
unii		495W7451VQ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE ASK DOCTOR BEFORE USE IF YOU HAVE: PERSISTENT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS) COUGH ACCOMPANIED BY EXCESSIVE PHLEGM STOP USE AND ASK A DOCTOR IS COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION. IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.