FDA.reportPublic FDA data

CVS dye-free childrens allergy

Product NDC
51316-710
Requested package NDC
51316-710-08
11-digit product format
513160710
Labeler code
51316
Product ID
51316-710_483f1ed8-8525-4f47-a6c7-01bb4f8fc338
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
CVS PHARMACY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
CVS dye-free childrens allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db5a5eff-1bb1-4d00-8c01-caae7a1c7223Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-710-08CVS dye-free childrens allergy1 in 1 CARTONSYRUP15
51316-710-08CVS dye-free childrens allergy236 mL in 1 BOTTLE, PLASTICSYRUP2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-710CVS DYE-FREE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [CVS PHARMACY]4Current NDC, Legacy NDC, 2 package rows20240822_db5a5eff-1bb1-4d00-8c01-caae7a1c7223.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 166 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae52024-04-06WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HBR, GUAIFENESINDEXTROMETHORPHAN HBR, GUAIFENESINOPMX LLC9a16e7f3-78aa-0b01-e053-2a95a90ab19c2024-04-05WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Honey GingerACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC44404c6a-8031-4f4b-a48e-3739a11a0d2c2024-04-05WarningsExact identifier
application number: M012
ActivcinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.e06a4d72-cc8d-fd9d-e053-2995a90a7a762024-04-05WarningsExact identifier
application number: M012
Coldtac Plus SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5ce5c6-a03f-2ad3-e053-6394a90a99f62024-04-05WarningsExact identifier
application number: M012
Desresfriol-DX SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5e0e0f-bfd2-b02b-e053-6394a90afe8a2024-04-05WarningsExact identifier
application number: M012
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc98bf8e84-b555-4b5a-90a0-7837a55602892024-04-03WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAdvanced Rx LLC38299cf3-e884-4676-8cc4-6dd64e7d023c2024-03-30WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEAdvanced Rx LLCd1542362-19c5-4470-89e8-87d26e2ca8ed2024-03-30WarningsExact identifier
application number: M012
ANTIGRIP NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLPharmadel LLC12de30fd-95b6-f16d-e063-6294a90aeba22024-03-27WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)0044c53c-11dd-41a9-a5d9-622dd8b1c1442024-03-27WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINBryant Ranch Prepack9812056b-736e-40c5-ae60-21dd9221397c2024-03-22WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)1b7b5811-722e-4c4a-844d-c05fa5cfb2e52024-03-21WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensda2a77c3-7d0f-157b-e053-2995a90a951a2024-03-19WarningsExact identifier
application number: M012
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC6bec225e-a203-4866-b0db-b76f73a6ae252024-03-19WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)06d47104-a8ca-48cc-b27e-08c9d018c37b2024-03-19WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b80dae7f-ed2d-4a9e-bef9-f1ed8add01742024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWALGREENSc945c35e-de0d-0fd6-e053-2995a90a1fbf2024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL/ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE,PHENYLEPHRINE HCLWalgreensda046b01-707c-326a-e053-2995a90a09272024-03-19WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME SEVERE COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensda2b0276-9ab0-38e6-e053-2a95a90a54d82024-03-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYdb5a5eff-1bb1-4d00-8c01-caae7a1c72235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51316-710-08513160710081 BOTTLE, PLASTIC in 1 CARTON (51316-710-08) / 236 mL in 1 BOTTLE, PLASTIC2022-07-220000-00-00NoNoCurrent