Childrens Allergy Relief

Product NDC
69168-471
11-digit product format
691680471
Labeler code
69168
Product ID
69168-471_00634319-dc1f-442f-a4f4-1c0a4c6c58da
Type
HUMAN OTC DRUG
Nonproprietary name
Childrens Allergy Relief
Dosage form
LIQUID
Route
ORAL
Labeler
Allegiant Health
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-07
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
Childrens Allergy Relief
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
cb6df361-b8e5-4e2f-945f-c20159d76c4fAvailable 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
69168-471-59Childrens Allergy Relief1 in 1 CARTONLIQUID13
69168-471-59Childrens Allergy Relief237 mL in 1 BOTTLELIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-471CHILDRENS ALLERGY RELIEF LIQUID [ALLEGIANT HEALTH]3Current NDC, 2 package rows20250215_cb6df361-b8e5-4e2f-945f-c20159d76c4f.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 83 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Afrin No Drip Pump Mist Bundle PackOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.16c52c79-baec-87db-e063-6294a90a3b3b2025-12-04WarningsExact identifier
application number: M012
Afrin Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.0f5ec576-f788-40aa-9088-0dd672e3cc7c2025-12-04WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corp432a79a9-c69d-4514-894a-7832e1b745ef2025-12-04WarningsExact identifier
application number: M012
GENCONTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS69d16d25-b09b-430e-8e01-0962d840dc212025-12-04WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLH E B7c04ab14-af28-4598-90ef-56ac11902c7d2025-12-04WarningsExact identifier
application number: M012
Desgen PediatricDEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCLKramer Novis12425c1b-8bdc-446b-83dd-95e05a4d9b8c2025-12-04WarningsExact identifier
application number: M012
Presgen BDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5befa829-32bd-4978-8a0e-1d6513ff37a42025-12-03WarningsExact identifier
application number: M012
TUSSLINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKramer Novis987e19a5-032f-44e9-b4c7-8a764d5026952025-12-03WarningsExact identifier
application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.450e8974-8ff8-4b82-e063-6394a90a93662025-12-03WarningsExact identifier
application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store Products, Inc.4510223f-1c88-2796-e063-6394a90a18ac2025-12-03WarningsExact identifier
application number: M012
Carolina Crud CrusherDEXTROMETHORPHAN HBR, GUAIFENESINWeeks & Leo Co., Inc.0b606683-7d68-cca5-e063-6394a90a6f582025-12-03WarningsExact identifier
application number: M012
Capmist DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECapital Pharmaceutical, LLC63733ac3-859e-4a8e-8717-d852bd3034082025-12-03WarningsExact identifier
application number: M012
ALA-HIST IRDEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.0d203b5c-8b10-428b-8703-17be6b4ce6eb2025-12-03WarningsExact identifier
application number: M012
ALAHIST DMDEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.fdaa062d-110e-798d-e053-6394a90a755c2025-12-03WarningsExact identifier
application number: M012
Alahist DPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.a1b8533a-ef8b-57cc-e053-2995a90a5d9e2025-12-03WarningsExact identifier
application number: M012
Alahist PEDEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.ada2d582-5813-2029-e053-2a95a90ae5672025-12-03WarningsExact identifier
application number: M012
Benadryl Allergy Extra Strength Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC30aca3ab-b091-3939-e063-6294a90a98192025-12-03WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRL.N.K. International, Inc.9f2daffc-1904-4d64-9f84-689c88601e062025-12-03WarningsExact identifier
application number: M012
Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.d291faa9-894e-421c-8115-8a8c2a9371722025-12-03WarningsExact identifier
application number: M012
SINUS PAIN AND CONGESTIONACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS Pharmacy697dffdd-5b56-4395-8e69-6b4360d9fdc52025-12-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNcb6df361-b8e5-4e2f-945f-c20159d76c4f3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDcb6df361-b8e5-4e2f-945f-c20159d76c4f3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYcb6df361-b8e5-4e2f-945f-c20159d76c4f3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYcb6df361-b8e5-4e2f-945f-c20159d76c4f3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYcb6df361-b8e5-4e2f-945f-c20159d76c4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-471-59691680471591 BOTTLE in 1 CARTON (69168-471-59) / 237 mL in 1 BOTTLE1 bottle2025-01-07NoNoCurrent