FDA.reportPublic FDA data

Childrens Allergy

Product NDC
49580-0292
11-digit product format
495800292
Labeler code
49580
Product ID
49580-0292_79fc4013-85e6-4276-bc54-26ac0951bd0e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-31
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
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
8559be55-8b00-4353-8e26-b5dff2ada806Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0292-2Childrens Allergy118 mL in 1 BOTTLE, PLASTICLIQUID1188
49580-0292-4Childrens Allergy1 in 1 BOXLIQUID18
49580-0292-4Childrens Allergy118 mL in 1 BOTTLE, PLASTICLIQUID1188

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AARON INDUSTRIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0292CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]7Current NDC, Legacy NDC, 3 package rows20240217_8559be55-8b00-4353-8e26-b5dff2ada806.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 117 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
application number: M012
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
application number: M012
daytime severe cold multi-symptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd2025-03-08WarningsExact identifier
application number: M012
Cold and Head Congestion Relief SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLCa39778ba-1f63-4495-8e9b-44b0bdd7f71a2025-03-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
application number: M012
Herbal Cough Drops Original HerbCOUGH DROPSTopco Associates LLC2fb22181-aee3-d0bf-e063-6294a90a78652025-03-06WarningsExact identifier
application number: M012
REVASOL DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERnv LLC2f9ddcc3-b913-f8b0-e063-6294a90a93ab2025-03-05WarningsExact identifier
application number: M012
Herbal Throat Drops Lemon Mint HerbTHROAT DROPSTopco Associates LLC2fa086b4-3b0e-0df8-e063-6294a90a67692025-03-05WarningsExact identifier
application number: M012
Redicare Nasal and Sinus DecongestantREDICARE NASAL AND SINUS DECONGESTANTRedicare LLC2f24be68-f30e-d916-e063-6294a90a7e312025-03-04WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORAL SOLUTIONKesin Pharma Corporation2f871005-de4d-8b2a-e063-6394a90aa43a2025-03-04WarningsExact identifier
application number: M012
CVS Daytime Cough Relief Chews - Citrus PunchDEXTROMETHORPHAN HBRCVS2f885f1b-7ff5-251b-e063-6394a90a656f2025-03-04WarningsExact identifier
application number: M012
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCff8b096c-8f01-4a8c-a98f-e4aa4d688e952025-03-04WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOL7-ELEVEN2f3c43dd-175f-722e-e063-6294a90acff92025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTIN7-ELEVEN2f3c3c65-4178-6304-e063-6294a90a51fa2025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efbffd7-bbdd-c5f5-e063-6294a90a15f02025-02-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN8559be55-8b00-4353-8e26-b5dff2ada8068
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD8559be55-8b00-4353-8e26-b5dff2ada8068
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY8559be55-8b00-4353-8e26-b5dff2ada8068
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY8559be55-8b00-4353-8e26-b5dff2ada8068
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY8559be55-8b00-4353-8e26-b5dff2ada8068

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0292-249580029202118 mL in 1 BOTTLE, PLASTIC (49580-0292-2) 118 ml2015-03-310000-00-00NoNoCurrent
49580-0292-4495800292041 BOTTLE, PLASTIC in 1 BOX (49580-0292-4) / 118 mL in 1 BOTTLE, PLASTIC2015-03-310000-00-00NoNoCurrent