FDA.reportPublic FDA data

NDC 65090-001 - AniHist

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65090-001
Package NDCs from labels
65090-001-15, 65090-001-30
Manufacturer
AHC Products Inc | Delta Synthetic Co., Ltd. | Supriya Lifescience Ltd.
Effective date
2022-01-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsAHC Products Inc | Delta Synthetic Co., Ltd. | Supriya Lifescience Ltd.2022-01-21OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65090-001-15AniHist566 g in 1 JARGRANULE566117
65090-001-30AniHist2264 g in 1 PAILGRANULE2264117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65090-001ANIHIST (GUAFENESIN AND PYRILAMINE MALEATE) GRANULE [AHC PRODUCTS INC]1172 package rows20220203_c54f1636-bb8c-4181-a6d5-14ab1c8a47fd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQANIHIST (GUAFENESIN AND PYRILAMINE MALEATE) GRANULE [AHC PRODUCTS INC]115
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZAANIHIST (GUAFENESIN AND PYRILAMINE MALEATE) GRANULE [AHC PRODUCTS INC]115
GUAIFENESINACTIVE MOIETY495W7451VQANIHIST (GUAFENESIN AND PYRILAMINE MALEATE) GRANULE [AHC PRODUCTS INC]115
PYRILAMINEACTIVE MOIETYHPE317O9TLANIHIST (GUAFENESIN AND PYRILAMINE MALEATE) GRANULE [AHC PRODUCTS INC]115

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 68 of 68 · 1,353 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin Extended-Release 600 mgGUAIFENESINGuardian Drug Company20f9e083-419d-429d-a570-24b312ed5d2a2018-02-28WarningsExact identifier
unii: 495W7451VQ
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
unii: 495W7451VQ
Tukol ADEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.651f0d7c-c76b-434d-95fd-427609b40b462017-12-28WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINAphena Pharma Solutions - Tennessee, LLC1c84bf00-ebaa-4e69-a2c6-716631d209d92017-12-18WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESIN 400 MGRichmond Pharmaceuticals, Inc.26924bee-32cc-4499-beb0-2650ff8eb1da2017-10-30WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRRichmond Pharmaceuticals, Inc59b00858-e5c9-420a-bc7e-46953722cde62017-10-30WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAdvance Pharmaceutical Inc.e507a84a-59d5-47f2-a2df-f342e4b093b42017-10-30WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESIN 400 MGAdvance Pharmaceutical Inc.5b78bbe9-806c-443f-bc23-351e5342355f2017-10-30WarningsExact identifier
unii: 495W7451VQ
maximum strength mucus relief severe congestion and coughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESuperValu Inc.,3bb76952-15d8-4a36-a392-60f62b845f092017-09-01WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLSUPERVALU INCbe535a56-1b95-424e-8197-566976ef2efa2017-09-01Warnings, Adverse reactionsExact identifier
unii: 495W7451VQ
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL523561fb-f6a7-4cde-9be2-bba02e60e2082017-04-06WarningsExact identifier
unii: 495W7451VQ
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
unii: 495W7451VQ
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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