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 40 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leadere7ad8d2d-01fd-40d9-a972-b2ca14cc97fb2026-04-09WarningsExact identifier
application number: M012
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLL.N.K. International, Inc.e20b1093-d77f-4c39-b105-adaa1b82ea762026-04-09WarningsExact identifier
application number: M012
Alka Seltzer Cold Cold and Congestion Severe Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.4f0c1b8e-3fb1-ccf2-e063-6394a90acd152026-04-09WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATELidl US LLCb26ac105-f8e4-4ad0-8a26-9fdf30c017002026-04-09WarningsExact identifier
application number: M012
Wal Dryl Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEWalgreens09de28cd-fa60-4af7-b7cc-cf74c00a35312026-04-09WarningsExact identifier
application number: M012
Tussin DM Max NIGHTTIMEDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyd10a413e-22a6-4799-8367-5777831756a92026-04-09WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader80d25e23-b108-4eb1-88c7-73fe9da8f9422026-04-09WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR AND GUAIFENESINL.N.K. International, Inc.2fea3533-8218-4875-affe-5b33a22c553a2026-04-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Plus Chest CongestionACETAMINOPHEN, GUAIFENESINKenvue Brands LLC4e60e1ad-4ad4-c329-e063-6294a90ab3182026-04-08WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4592d547-556f-4eec-8faf-6ff9a92e46c82026-04-08WarningsExact identifier
application number: M012
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.e24121d2-c9d2-4bbd-869e-eeed7e2bb8812026-04-08WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLStrategic Sourcing Services LLC8460d4f9-8d7b-4ae4-8047-c2010d9c80132026-04-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leaderd2dab450-cf82-4be2-a4e2-630295fb59ab2026-04-08WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens4657c02b-887b-4746-8a78-83a72465e07b2026-04-08WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC76e19b9a-3bdb-479a-9503-9e8250109c842026-04-07WarningsExact identifier
application number: M012
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.7959ea00-2a41-4c3c-8c58-85795ebd2afc2026-04-06WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPreferred Pharmaceuticals Inc.da148c1d-e394-4367-83e0-533469501b302026-04-06WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRTOP CARE (Topco Associates LLC)b2ebfeb3-e248-40bf-81d3-81c5fb532dbe2026-04-06WarningsExact identifier
application number: M012
Allergy Plus Sinus ReliefDIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLRite Aid Corporation54623e2e-5f9a-426e-8f7e-ea755ff8b3f82026-04-06WarningsExact 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