FDA.reportPublic FDA data

Meijer Childrens Allergy Relief

Product NDC
41250-710
11-digit product format
412500710
Labeler code
41250
Product ID
41250-710_f2ed3222-6271-45ba-ae5e-dd94bc5f9f11
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-07
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
2027-12-31
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
Meijer Childrens Allergy Relief
Brand name suffix
Bubblegum flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-710-08Meijer Childrens Allergy ReliefBubblegum flavor118 mL in 1 BOTTLE, PLASTICLIQUID1188
41250-710-08Meijer Childrens Allergy ReliefBubblegum flavor1 in 1 CARTONLIQUID18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-710MEIJER CHILDRENS ALLERGY RELIEF BUBBLEGUM FLAVOR (DIPHENHYDRAMINE HCL) LIQUID [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 2 package rows20241020_d3f7b0ee-51e8-466f-ad9f-98ac879c330a.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 137 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATETopco Associates LLCa2929bcb-fa81-4f15-b087-a9996b5e7d1f2024-11-13WarningsExact identifier
application number: M012
Equate Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalmart6271bb48-74b2-eb57-e053-2991aa0afd1b2024-11-13WarningsExact identifier
application number: M012
Equaline Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEUnited Natural Foods, Inc. dba UNFI6bf341e0-94b1-08ff-e053-2991aa0af6342024-11-13WarningsExact identifier
application number: M012
Good Sense Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEGood Sensecd25e250-bb8b-7e83-e053-2a95a90a26392024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd440a00b1-7960-0cc4-e054-00144ff8d46c2024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd.c6f207e8-bc0d-853a-e053-2a95a90ac6232024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEDOLGENCORP, LLC7fad8e65-34fe-5313-e053-2a91aa0a56f42024-11-13WarningsExact identifier
application number: M012
Dollar General Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATEDOLGENCORP, LLC7face5c7-f5c7-7eee-e053-2991aa0ab0642024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEChain Drug Marketing Association90622927-9682-4eb0-8c7f-894230b3dda42024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca2024-11-13WarningsExact identifier
application number: M012
WinCo Foods Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEWinCo Foods, LLCd443a030-d3d6-40e0-8fe0-329de6bc494f2024-11-13WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Company954fe703-9a10-4354-8b71-4d98a22a0b9f2024-11-13WarningsExact identifier
application number: M012
NASAL DECONGESTANT PEPHENYLEPHRINE HCLA-S Medication Solutions9d030767-dfd6-48b4-9b17-4e20c23915f32024-11-13WarningsExact identifier
application number: M012
Childrens SUDAFED PE Cold plus CoughDEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC20e45243-3989-413a-bcf1-49d754ff2e442024-11-12WarningsExact identifier
application number: M012
Tukol Cough And Cold Honey FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAa4b333dc-58da-45db-87b6-6fcb8fb542b82024-11-12WarningsExact identifier
application number: M012
daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company4b49137c-8fc9-43b7-b1a1-82e318237eb62024-11-12WarningsExact identifier
application number: M012
CVS Original Nasal MistOXYMETAZOLINE HCLCVS PHARMACY, INCe9c551a0-cd78-4272-b42f-36c096d267362024-11-12WarningsExact identifier
application number: M012
up and up cough plus chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINTarget Corporationed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c2024-11-12WarningsExact identifier
application number: M012
DG Health Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Incb33d104b-0b4d-40c6-8345-c2c7403273312024-11-11WarningsExact identifier
application number: M012
Zephrex DPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company5468a7e2-361b-494f-9ca3-1b62f3819f652024-11-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNd3f7b0ee-51e8-466f-ad9f-98ac879c330a8
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDd3f7b0ee-51e8-466f-ad9f-98ac879c330a8
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYd3f7b0ee-51e8-466f-ad9f-98ac879c330a8
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYd3f7b0ee-51e8-466f-ad9f-98ac879c330a8
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYd3f7b0ee-51e8-466f-ad9f-98ac879c330a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-710-08412500710081 BOTTLE, PLASTIC in 1 CARTON (41250-710-08) / 118 mL in 1 BOTTLE, PLASTIC2017-03-070000-00-00NoNoCurrent