Viro-Flu AM

Product NDC
69729-831
11-digit product format
697290831
Labeler code
69729
Product ID
69729-831_5d1fb591-f73f-dfe4-e063-6294a90abd88
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
OPMX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-25
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 5; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Viro-Flu AM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

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 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC1695e7ea-2f83-4d3a-980e-c91be6c1f2a52025-12-25WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINPharbest Pharmaceuticals, Inc.0bf70fb4-d3c8-476d-b864-4eadc697a7d82025-12-24WarningsExact identifier
application number: M012
PHARBINEX-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGPharbest Pharmaceuticals, Inc.8d71db43-da87-45ee-aa4a-7e870bc5016d2025-12-24WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway, Inc.764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be2025-12-23WarningsExact identifier
application number: M012
TussinGUAIFENESINDiscount Drug Mart14de3d6d-4eb0-42cf-8941-cb42b3dd5c712025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCc8dcba06-a461-4af5-a120-666a63f06ac42025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN MAX STRENGTH MS Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES920bde5f-4079-45de-aa59-24b00e50cb562025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46996bbf-948c-0aba-e063-6394a90a09e32025-12-23WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.1d2e2a5a-099b-41b3-82bd-5bf704377f782025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.8f320235-f243-4211-b99c-18526e6865482025-12-23WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.b6a46498-d9a8-4da2-9283-57d135f305a52025-12-23WarningsExact identifier
application number: M012
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.7c5faec2-28c6-4c15-a268-d8b578140b742025-12-23WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLWalmart67650b94-adbb-87fb-e053-2a91aa0a87e62025-12-23WarningsExact identifier
application number: M012
Equate Benz-Dex Cough and Throat LozengesBENZOCAINEWalmartc0a6cb7f-a247-e610-e053-2a95a90a41992025-12-23WarningsExact identifier
application number: M012
Equate Honey Lemon Cough DropsMENTHOLWalMart0028be18-5162-ff51-e063-6294a90ae5172025-12-23WarningsExact identifier
application number: M012
Equate SF Menthol Cough DropsMENTHOLWalMart003a229c-b014-e9f3-e063-6294a90aa5ed2025-12-23WarningsExact identifier
application number: M012
Equate Menthol Cough DropsMENTHOLWalmart124e6968-f59c-39d4-e063-6294a90a66d42025-12-23WarningsExact identifier
application number: M012
Equate Severe Menthol Throat DropMENTHOLWalmart125f3f5a-52aa-e398-e063-6394a90a00122025-12-23WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-831-02697290831022 CAPSULE, LIQUID FILLED in 1 POUCH (69729-831-02) 2026-06-25NoNoCurrent
69729-831-506972908315025 POUCH in 1 CARTON (69729-831-50) / 2 CAPSULE, LIQUID FILLED in 1 POUCH25 pouch2026-06-25NoNoCurrent