FDA.reportPublic FDA data

Winco Foods Childrens Allergy Relief

Product NDC
67091-354
11-digit product format
670910354
Labeler code
67091
Product ID
67091-354_de7d1e71-4afe-4121-9d35-5b1c438ed2c3
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
WINCO FOODS, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-09
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
Winco Foods Childrens Allergy Relief
Brand name suffix
Dye Free
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
a1367804-37c9-4906-858f-8feeb748d8d3Available 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
67091-354-18Winco Foods Childrens Allergy ReliefDye Free1 in 1 CARTONSOLUTION16
67091-354-18Winco Foods Childrens Allergy ReliefDye Free118 mL in 1 BOTTLE, PLASTICSOLUTION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-354WINCO FOODS CHILDRENS ALLERGY RELIEF DYE FREE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WINCO FOODS, LLC]5Current NDC, Legacy NDC, 2 package rows20241121_a1367804-37c9-4906-858f-8feeb748d8d3.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 57 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Honey Lemon Cough DropsMENTHOLCVS Pharmacyde963dc3-8108-440f-e053-2995a90a906f2026-01-16WarningsExact identifier
application number: M012
CVS SF Menthol Cough DropsMENTHOLCVS Pharmacye08f8ca3-b683-4964-e053-2a95a90afabb2026-01-16WarningsExact identifier
application number: M012
CVS SF Honey Lemon Cough DropsMENTHOLCVS Pharmacye0cdeccf-c32f-318a-e053-2a95a90ac4012026-01-16WarningsExact identifier
application number: M012
Mixed Berry Throat and Cough LozengesBENZOCAINECVS Pharmacy737b1c88-1a44-68cf-e053-2991aa0a35b62026-01-16WarningsExact identifier
application number: M012
Walgreens Wild Cherry Throat DropsPECTINWalgreens4885eca3-c1e9-8350-e063-6394a90ac2902026-01-16WarningsExact identifier
application number: M012
HBP Chest Congestion and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensff7a1462-9994-4421-85aa-c03488bb04cf2026-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRWALGREEN COMPANYa793acbc-107c-4638-a2d7-65f4e96cafda2026-01-16WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensca53ec26-d167-1780-e053-2a95a90a5b882026-01-16WarningsExact identifier
application number: M012
Maximum Strength Congestion and HeadacheACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens88da92d2-92c2-445a-9b70-58996e0860142026-01-16WarningsExact identifier
application number: M012
Maximum Strength Cold and FluACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens5f638bca-55c2-4ead-8c47-3f15713495da2026-01-16WarningsExact identifier
application number: M012
COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens190175bb-c08a-4050-aacf-29a130cbe05c2026-01-16WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEFSA Store Inc. (Caring Mills)a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff2026-01-16WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLL.N.K. International, Inc.99147338-f459-4423-ae54-f96fffc1728d2026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC144aafcc-6ec2-a322-e063-6294a90afc272026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC14484bf5-ff45-b859-e063-6394a90a9a0f2026-01-15WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLC3429aedc-e83d-498a-bfca-03aaf5847b3b2026-01-15WarningsExact identifier
application number: M012
Quality Choice Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association4b86101c-00f8-4ede-807f-db4273b37b8d2026-01-15WarningsExact identifier
application number: M012
Quality Choice Mucus Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINChain Drug Marketing Associationd1ba7267-6844-4a14-b518-65277a32e8552026-01-15WarningsExact identifier
application number: M012
ACTINEL DM PediatricDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLCf85d8586-423f-48a3-9bb2-bbc5984c7cd32026-01-15WarningsExact identifier
application number: M012
ACTINEL DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINACTIPHARMA, LLC35c21623-84dd-4151-b35b-e7d30b69c9c02026-01-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNa1367804-37c9-4906-858f-8feeb748d8d36
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDa1367804-37c9-4906-858f-8feeb748d8d36
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYa1367804-37c9-4906-858f-8feeb748d8d36
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYa1367804-37c9-4906-858f-8feeb748d8d36
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYa1367804-37c9-4906-858f-8feeb748d8d36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-354-18670910354181 BOTTLE, PLASTIC in 1 CARTON (67091-354-18) / 118 mL in 1 BOTTLE, PLASTIC2020-03-090000-00-00NoNoCurrent