FDA.reportPublic FDA data

BACTIMICINA CHILDRENS ALLERGY

Product NDC
24286-1565
11-digit product format
242861565
Labeler code
24286
Product ID
24286-1565_35309ddf-ca00-1b7d-e063-6294a90a25c7
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
DLC Laboratories, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-17
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
BACTIMICINA 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
eaf554d4-a758-4ed6-bec5-d6cbfedae408Available 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
24286-1565-4BACTIMICINA CHILDRENS ALLERGY118 mL in 1 BOTTLELIQUID1186
24286-1565-4BACTIMICINA CHILDRENS ALLERGY1 in 1 CARTONLIQUID16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24286-1565BACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]6Current NDC, Legacy NDC, 2 package rows20250516_eaf554d4-a758-4ed6-bec5-d6cbfedae408.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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe44d1ee-1e03-b74f-e053-6294a90a8bb42026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC325b41e1-f8d2-02ee-e063-6394a90aafff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC326f1fd3-73ab-e515-e063-6294a90ab2222026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6c85df30-a601-4de6-9fd6-818265d799ff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and Cool Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2ee95e17-bd94-d717-e063-6294a90a21732026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Sinus Pressure Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2eeafd83-230c-af92-e063-6294a90a984e2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
application number: M012
Childrens Mucinex Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC60daf6e2-ded8-44e6-bd8d-9d221384adde2026-05-19WarningsExact identifier
application number: M012
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, NightDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINWALMART INC.312ae879-1124-40a4-b2ba-3f30708400212026-05-19WarningsExact identifier
application number: M012
GOOD SENSE DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2597e84c-18b4-41a9-8e6a-ff0c4c1f06122026-05-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNeaf554d4-a758-4ed6-bec5-d6cbfedae4086
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDeaf554d4-a758-4ed6-bec5-d6cbfedae4086
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYeaf554d4-a758-4ed6-bec5-d6cbfedae4086
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYeaf554d4-a758-4ed6-bec5-d6cbfedae4086
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYeaf554d4-a758-4ed6-bec5-d6cbfedae4086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24286-1565-4242861565041 BOTTLE in 1 CARTON (24286-1565-4) / 118 mL in 1 BOTTLE1 bottle2015-06-170000-00-00NoNoCurrent