FDA.reportPublic FDA data

Pain, Headache and Cough

Product NDC
51316-803
11-digit product format
513160803
Labeler code
51316
Product ID
51316-803_9d0ed71c-c1ac-498d-8174-98c687cc5696
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-21
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 10 mg/1; mg/1
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
Pain, Headache and Cough
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2709673Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
613a2516-fc61-4bb4-bd44-ca6004548193Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-803-09Pain, Headache and Cough10 in 1 BLISTER PACKTABLET, FILM COATED102
51316-803-09Pain, Headache and Cough2 in 1 CARTONTABLET, FILM COATED22

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 163 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a2024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)dbfb8971-a122-4a97-a665-e3f0d494876e2024-05-01WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLCc08b150c-d821-466c-8521-f77535d6af1e2024-04-30WarningsExact identifier
application number: M012
childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreen Company7848bb09-2af8-47f6-b32d-96635a750a552024-04-29WarningsExact identifier
application number: M012
NASAL and SINUS DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEJHK Inc dba American Safety & First Aid63e51305-2575-49c4-9fda-7b3e1b4b6ede2024-04-26WarningsExact identifier
application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat NighttimeACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHaleon US Holdings LLC7decc168-e847-4bbe-910b-26081469406f2024-04-26WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC7c92bdcf-db1f-4299-982f-6a3da9cba6e62024-04-25WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC15727e06-7bfc-424e-9e68-cc9cd5695bfd2024-04-25WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC5872fed8-862b-44a2-a06e-51ebf86182712024-04-25WarningsExact identifier
application number: M012
CHERRY COUGH DROPS 50CTMENTHOL, UNSPECIFIED FORMJHK Inc dba American Safety & First Aid2f54b9c1-3a37-48fd-b964-6aa2631b8e622024-04-24WarningsExact identifier
application number: M012
Dye Free Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)f1a33c2f-2330-43f3-8026-de21808aec662024-04-22WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)fc7954a6-d061-4160-b1d1-a19eb9eabff42024-04-22WarningsExact identifier
application number: M012
Dibromm Cold and Allergy ChildrensBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)ea285d5a-9eb4-4f71-bb1b-4e24a89728192024-04-22WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c573da1e-c7ca-46e6-ad42-4ded2547afc32024-04-22WarningsExact identifier
application number: M012
Cough Relief Cough SuppressantDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)13ae4c67-a3fe-440c-91b8-c9412626c3cd2024-04-22WarningsExact identifier
application number: M012
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)47660794-22cc-4863-a183-e694d27e35432024-04-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9c08b18-a119-406b-bd96-73572b4445e22024-04-18WarningsExact identifier
application number: M012
Nighttime Cough ReliefDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e1fa0f51-6a68-4f6f-8988-0949d1942c2f2024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)025f6622-a6db-4a5c-aebd-5d54172fa4a12024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9530d55-8226-4659-84f0-2c0b411572be2024-04-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletPSN613a2516-fc61-4bb4-bd44-ca60045481932
2709673acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCD613a2516-fc61-4bb4-bd44-ca60045481932
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletSY613a2516-fc61-4bb4-bd44-ca60045481932
2709673APAP 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSY613a2516-fc61-4bb4-bd44-ca60045481932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-803-09513160803092 BLISTER PACK in 1 CARTON (51316-803-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2026-04-21NoNoCurrent