FDA.reportPublic FDA data

CVS PHARMACY

Product NDC
51316-635
11-digit product format
513160635
Labeler code
51316
Product ID
51316-635_18c65cf1-b3d8-4764-8b5d-d77ea642df5d
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate,Dextromethorphan HBr,Diphenhydramine HCl
Dosage form
KIT
Labeler
CVS PHARMACY, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-03
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
CVS PHARMACY
Brand name suffix
COLD and COUGH And NIGHTTIME VALUE PACK
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049884Internal RxNorm lookup
2683421Internal RxNorm lookup
2683422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d94968b-ada3-4344-8563-cba7fc491d74Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-632-04CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK118 mL in 1 BOTTLE, PLASTICLIQUID118 mL2 mg in 10mL2
51316-635-08CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK1 in 1 KITKIT12
51316-646-04CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12.5 mg in 10mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-635CVS PHARMACY COLD AND COUGH AND NIGHTTIME VALUE PACK (BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL) KIT [CVS PHARMACY, INC.]1Current NDC, 3 package rows20250322_4d94968b-ada3-4344-8563-cba7fc491d74.zip

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 124 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Right Remedies Adult Long Lasting Cough Relief SoftgelDEXTROMETHORPHAN HYDROBROMIDEStrive Pharmaceuticals Inc.e3ea468e-4e12-4dae-b222-8e32456b77b82025-01-02WarningsExact identifier
application number: M012
AVON HeXashield Congestion Relief OriginalOXYMETAZOLINE HYDROCHLORIDETai Guk Pharm. Co., Ltd.8f2c152c-c564-0cba-e053-2a95a90ab3c72025-01-01WarningsExact identifier
application number: M012
Multi-Symptom Nighttime Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRAdvanced Rx LLCa75553bd-f3f0-47bd-b3c3-aeeb0d1a81b42025-01-01WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBRAdvanced Rx LLC64620186-a45b-4c35-a3b9-a347348f93f72025-01-01WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice57a44bbf-a304-47b9-8adc-4442c77878532025-01-01WarningsExact identifier
application number: M012
Long Acting Cough SoftgelsDEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INC322daee6-c61d-43d3-a54d-a354fd3df2422025-01-01WarningsExact identifier
application number: M012
Adult Tussin DM Lil Drug Store ProductsDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINLil' Drug Store Products, Inc1915cf2a-ebaa-4c47-8991-5b741fa01be22024-12-31WarningsExact identifier
application number: M012
Congestion Relief Lil Drug Store ProductsOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc8fca348c-ecb6-4a91-89dd-8bd4c05ac7452024-12-31WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOMDAYTIME COLD AND FLU MULTI SYMPTOMTARGET CORP9dea350d-2f09-b944-e053-2995a90a2b632024-12-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb2024-12-30WarningsExact identifier
application number: M012
Pediacare Childrens Cough and Cold GrapeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHfabafdc1-9dd8-4258-af49-bab1e29ad1092024-12-30WarningsExact identifier
application number: M012
Pediacare Childrens Cough and Congestion GrapeDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH9576723b-748c-45e7-bc0d-cc109b9f67352024-12-30WarningsExact identifier
application number: M012
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store Products, Inc.ef6836fa-d104-d7b3-e053-2a95a90af2b82024-12-30WarningsExact identifier
application number: M012
Circle K Congestion ReliefOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc7e02fe57-f42f-4d3c-9002-4c4c0b1fafd62024-12-30WarningsExact identifier
application number: M012
SDA Laboratories TussinGUAIFENESINSDA Laboratories, Inc.2a444cc8-96be-9432-e063-6394a90a1b632024-12-27WarningsExact identifier
application number: M012
SDA Laboratories Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINSDA Laboratories, Inc.2a445f31-818d-11b1-e063-6294a90a8cb12024-12-27WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals Inc.f184b2aa-91a4-44f9-b688-d4e3181819842024-12-26WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.2792032a-ff0f-4d5f-a8e3-b8b8c54f4e992024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.c7b1f980-9b0d-4f63-a70d-fd366658f8632024-12-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683422{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML Oral Solution) } PackGPCK4d94968b-ada3-4344-8563-cba7fc491d742
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution) PackPSN4d94968b-ada3-4344-8563-cba7fc491d742
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN4d94968b-ada3-4344-8563-cba7fc491d742
1049884diphenhydrAMINE HCl 50 MG in 40 mL Oral SolutionPSN4d94968b-ada3-4344-8563-cba7fc491d742
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD4d94968b-ada3-4344-8563-cba7fc491d742
1049884diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD4d94968b-ada3-4344-8563-cba7fc491d742
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution) / 1 nighttime (diphenhydramine HCl 12.5 MG per 10 mL Oral Solution) PackSY4d94968b-ada3-4344-8563-cba7fc491d742
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY4d94968b-ada3-4344-8563-cba7fc491d742
1049884diphenhydramine hydrochloride 50 MG per 40 ML Oral SolutionSY4d94968b-ada3-4344-8563-cba7fc491d742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-632-0451316063204118 mL in 1 BOTTLE, PLASTIC118 mlHistorical
51316-635-08513160635081 KIT in 1 KIT (51316-635-08) * 118 mL in 1 BOTTLE, PLASTIC (51316-632-04) * 118 mL in 1 BOTTLE, PLASTIC (51316-646-04) 1 kit2025-03-03NoNoCurrent
51316-646-0451316064604118 mL in 1 BOTTLE, PLASTIC118 mlHistorical