Vicks Formula 44 DM

Product NDC
84126-379
11-digit product format
841260379
Labeler code
84126
Product ID
84126-379_5d6c5047-e638-472b-e063-6394a90a683d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-07
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
650; 30 mg/30mL; mg/30mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Vicks Formula 44 DM
Brand name suffix
Painful Cough and Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL

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 142 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Adult Tussin DM MAXDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Services LLC5f6e4d56-4a66-4dbd-97c8-550310dea3582024-11-05WarningsExact identifier
application number: M012
Cough Drops Honey Lemon with SugarMENTHOLLidl US LLC4ad9398f-7488-6eaf-e054-00144ff8d46c2024-11-05WarningsExact identifier
application number: M012
rexall dm cough and congestion reliefDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLC906838b1-a742-4728-944d-42b687b8cd592024-11-05WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINH E B7c24c59c-7549-4c64-95f8-4bf755cd6f612024-11-05WarningsExact identifier
application number: M012
equate adult tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores Inc3592e000-a6c6-47fe-8bb0-9341c65c29592024-11-05WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company756794b0-8d3b-4732-947c-a407caf400e22024-11-05WarningsExact identifier
application number: M012
basic care tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCc6863e31-e1b9-40ff-ae2e-4aec86b4acc02024-11-05WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates LLC94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a2024-11-05WarningsExact identifier
application number: M012
Childrens Sudafed PE NASAL DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d2024-11-04WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.164b2559-2d3f-431e-a03c-07e86731af5c2024-11-04WarningsExact identifier
application number: M012
tussin severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E B7cc2c136-d1b7-4658-99bb-73bb1d1402612024-11-04WarningsExact identifier
application number: M012
dg health tussinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inca5d0ee70-d528-4a53-bf01-7bb13b364ed02024-11-04WarningsExact identifier
application number: M012
basic care tussin cf severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLCbba9a17d-eb87-46f3-acee-c9dd34e5bfd42024-11-04WarningsExact identifier
application number: M012
topcare tussin cf maxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCb553b7e6-933b-49e3-97d3-22a4643a04b92024-11-04WarningsExact identifier
application number: M012
dg health nasal originalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCfb209752-705a-4bb0-9298-8b70357f39112024-11-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B3c301993-642a-487c-96a2-ebc4ef90dc882024-11-02WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1341744c-43c3-462b-b93c-1e46476fd9352024-11-01WarningsExact identifier
application number: M012
Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy43784616-1afd-4ff7-8fee-6ac389f616a22024-11-01WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLC28ef87e8-29e5-444d-b1f7-5c38a7f758d32024-11-01WarningsExact identifier
application number: M012
Good Sense Severe NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Company0e3c36c9-d45b-41b9-891d-a42d854295f92024-11-01WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-379-1284126037912354 mL in 1 BOTTLE (84126-379-12) 354 ml2026-07-07NoNoCurrent