FDA.reportPublic FDA data

CVS Dex-Dox Kids Nighttime Cough Suppressant

Product NDC
51316-081
11-digit product format
513160081
Labeler code
51316
Product ID
51316-081_2f8b6f5e-399d-b033-e063-6294a90ac3d1
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
CHEWABLE GEL
Route
ORAL
Labeler
CVS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-04
Substance
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
6.25; 10 mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
2026-12-31
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 Dex-Dox Kids Nighttime Cough Suppressant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE6.25 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
V9BI9B5YI2Internal 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
2683423Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f8b6f5e-399c-b033-e063-6294a90ac3d1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-081-16CVS Dex-Dox Kids Nighttime Cough Suppressant16 in 1 BOTTLECHEWABLE GEL161

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-081CVS DEX-DOX KIDS NIGHTTIME COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) CHEWABLE GEL [CVS]1Current NDC, 1 package rows20250308_2f8b6f5e-399c-b033-e063-6294a90ac3d1.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 93 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWAL-MART STORES,INC.68a68574-0fcb-4569-be57-d9aee5f62bea2025-10-28WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,635009a1-6154-4c62-a4be-d4f32c2cef8d2025-10-28WarningsExact identifier
application number: M012
Publix Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCcf49a06d-f095-48bf-bcd2-a410066ff9af2025-10-28WarningsExact identifier
application number: M012
PublixOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INC283e42b9-173c-4deb-9377-ff649efc177f2025-10-28WarningsExact identifier
application number: M012
Publix Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCeae83b75-9d5a-4100-9304-629e54ef77522025-10-28WarningsExact identifier
application number: M012
PublixPHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCf10e120d-f0b7-4c51-b29b-e8cdbb1456f32025-10-28WarningsExact identifier
application number: M012
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0f8e9e-0503-522b-e053-2a91aa0aca352025-10-28WarningsExact identifier
application number: M012
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0eef2f-f546-d769-e053-2991aa0a8fe42025-10-28WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Congestion AdultDEXTROMETHORPHAN HBR, GUAIFENESINP & L Development, LLC4af67ba7-8892-442c-b9fb-80aba9140e052025-10-28WarningsExact identifier
application number: M012
No Drip Nasal Mist Nasal Decongestant Severe CongestionOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores,Inc.,994fa270-65bb-4097-b88a-d5ce3c0e1c792025-10-27WarningsExact identifier
application number: M012
Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWAL-MART STORES INC.3652ee94-b762-4100-a305-5acbec5f795a2025-10-27WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLWal-Mart Stores,Inc.,2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc2025-10-27WarningsExact identifier
application number: M012
Allergies MY CHILD NEEDS HELP WITHDIPHENHYDRAMINE HCLUnconditional Love5ad293e9-0a4b-4923-8a91-f014507268282025-10-27WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC4a9fd615-b7d3-452c-ac40-d9189124faaa2025-10-24WarningsExact identifier
application number: M012
allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Inc622b12fa-455c-4432-a9a2-698a929bbd682025-10-24WarningsExact identifier
application number: M012
Dristan 12 hrOXYMETAZOLINE HYDROCHLORIDEFoundation Consumer Brands522876fe-a412-4ca8-bfad-a313e3cbc1af2025-10-24WarningsExact identifier
application number: M012
Dimetapp Multi-Symptom Cold and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare178fe95b-e1ed-43b2-e063-6294a90a7a782025-10-24WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporationc831d3d9-b910-40e6-bfdf-defe6850614d2025-10-24WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation7d2f3292-bb73-41dc-9729-edb83670be1b2025-10-24WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLR.L. ALBERT & SON, INCb174e57c-4e4f-4842-b8f2-f1b067764a682025-10-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletPSN2f8b6f5e-399c-b033-e063-6294a90ac3d11
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletSCD2f8b6f5e-399c-b033-e063-6294a90ac3d11
2683423dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Chewable TabletSY2f8b6f5e-399c-b033-e063-6294a90ac3d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-081-165131600811616 CHEWABLE GEL in 1 BOTTLE (51316-081-16) 16 chewable gel2025-03-04NoNoCurrent