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 77 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401b58-8cf8-4067-e053-2995a90a68fc2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1ba37b8-4558-0808-e053-2995a90a9f5e2025-12-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb84f37bc-be37-4f2b-83ee-d7d1341844902025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b7c7fc-1068-f486-e053-2a95a90a8e8c2025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b9e0da-2c54-8b31-e053-2995a90a690b2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf6b3ca40-7638-477f-b800-4c28c40ff0a82025-12-11WarningsExact identifier
application number: M012
Allergy ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company0a6e3251-02e0-42c1-bdf3-51c77f88c17f2025-12-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC516ab016-31f9-4829-8b94-2f968933093c2025-12-11WarningsExact identifier
application number: M012
Sinus PE CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company5b9151b7-3e40-4f37-b3e0-4c0fa0115b712025-12-10WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDiscount Drug Mart2344c048-0550-4c31-b54e-a198910c490e2025-12-10WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACY, INCcf4eb4c4-68e0-4478-a81c-d3d1e66f5cc52025-12-10WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe, Lil Drug StoreACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Incf395c196-62d7-47ff-b38d-af37adf5980b2025-12-10WarningsExact identifier
application number: M012
Tylenol Sinus Severe, Lil Drug StoreACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Inc88b68447-b016-4d5b-a5e3-c4ebccb14f8c2025-12-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Incd956f1b8-91f8-424b-bb6c-704c445b6f4c2025-12-10WarningsExact identifier
application number: M012
good neighbor pharmacy day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergene5c1bd96-d27d-49c1-b3b8-eee53a145ef52025-12-10WarningsExact identifier
application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe67bf-2c66-61e6-e063-6394a90a7f8f2025-12-10WarningsExact identifier
application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe0f43-b92a-f947-e063-6394a90ab72c2025-12-10WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7285fe0-5a5b-42c4-be47-9a07a2ba75e82025-12-10WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporationf9b8dbe1-7ff9-4320-850c-6e86e98d43932025-12-09WarningsExact identifier
application number: M012
Severe NasalOXYMETAZOLINE HYDROCHLORIDE 0.05%ALAINA HEALTHCARE PRIVATE LIMITED27747a10-8d1d-41c2-80b9-45452f3b9abc2025-12-09WarningsExact 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