FDA.reportPublic FDA data

Topcare childrens allergy

Product NDC
36800-379
11-digit product format
368000379
Labeler code
36800
Product ID
36800-379_8febc051-c865-4f72-8389-84bdb89f1ee6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1987-12-15
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
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
Topcare childrens allergy
Listing expiration
2026-12-31

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
6b784cde-3152-4421-a825-dd1fc601aa7aAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-379-262024-01-30C16284748780-11030e365-5e3a-111a-e063-dadaa90a10e2Topco Associates LLC. Children's Allergy Liquid Drug Facts
36800-379-342024-01-30C16284748780-11030e365-5e3a-111a-e063-dadaa90a10e2Topco Associates LLC. Children's Allergy Liquid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-379-26Topcare childrens allergy118 mL in 1 BOTTLESOLUTION1187
36800-379-26Topcare childrens allergy1 in 1 CARTONSOLUTION17
36800-379-34Topcare childrens allergy1 in 1 CARTONSOLUTION17
36800-379-34Topcare childrens allergy237 mL in 1 BOTTLESOLUTION2377

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-379-26ML - Milliliter36800-37985320ba8-48dc-468d-acf4-89f510eb265c12012-07-24
36800-379-34ML - Milliliter36800-37969b253e8-e012-437e-9b55-2be7290d451b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40TOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2TOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-379TOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 4 package rows20240724_6b784cde-3152-4421-a825-dd1fc601aa7a.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 31 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX Rapid Clear Day Night and Clear and Cool NasalACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC37dcb0ed-df56-1bec-e063-6394a90a695e2026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC373e0d75-8def-4b98-e063-6394a90a5e472026-05-13WarningsExact identifier
application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASALOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC5a397466-8721-4060-a178-5ebfd7069cc92026-05-13WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC350764de-7801-b24e-e063-6394a90ab3c32026-05-13WarningsExact identifier
application number: M012
Cepacol Extra Strength Sore Throat and CoughBENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc0cc32db-90f0-4106-8538-89821083ece12026-05-13WarningsExact identifier
application number: M012
Mucinex Cold and FluACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLCe8bc4131-f7b0-926a-e053-2995a90a40ac2026-05-13WarningsExact identifier
application number: M012
Mucinex Cold, Flu, and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC37ded76a-ee8d-f22c-e063-6394a90a00c22026-05-13WarningsExact identifier
application number: M012
Mucinex Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCfdb5c937-c148-eb46-e053-6394a90a8bed2026-05-13WarningsExact identifier
application number: M012
Mucinex Cough Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINReckitt Benckiser LLCe9c32d81-cd9b-4ff2-e053-2995a90aa4992026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC316b5569-b66f-f30c-e063-6394a90ae1472026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCd9467ca2-df75-4fa1-92b3-d2101eb54a772026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC12420092-3ef6-464b-9106-2d56cd6ef2002026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC09fdf96f-345f-43f2-9f0f-8303ac70849e2026-05-13WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc2ac53cc7-000f-41fd-b799-4e6d6886fe622026-05-13WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc2201d5c0-bd51-47a7-9775-916b185736232026-05-13WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLCf868e4a0-e9fb-4e6a-9984-29a2182462412026-05-13WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Inc582fa36b-6d0c-4ff3-80ab-6e0da4b209e42026-05-13WarningsExact identifier
application number: M012
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsExact identifier
application number: M012
Allergy Relief mini SoftgelsDIPHENHYDRAMINE HCI 25 MGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdf1c620b-ff59-4126-99a5-1d6750888f2b2026-05-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN6b784cde-3152-4421-a825-dd1fc601aa7a7
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD6b784cde-3152-4421-a825-dd1fc601aa7a7
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY6b784cde-3152-4421-a825-dd1fc601aa7a7
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY6b784cde-3152-4421-a825-dd1fc601aa7a7
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY6b784cde-3152-4421-a825-dd1fc601aa7a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-379-26368000379261 BOTTLE in 1 CARTON (36800-379-26) / 118 mL in 1 BOTTLE1 bottle1987-12-150000-00-00NoNoCurrent
36800-379-34368000379341 BOTTLE in 1 CARTON (36800-379-34) / 237 mL in 1 BOTTLE1 bottle2003-11-180000-00-00NoNoCurrent