FDA.reportPublic FDA data

Kosher Meds Childrens Allergy Relief

Product NDC
82179-004
11-digit product format
821790004
Labeler code
82179
Product ID
82179-004_18844590-5a14-4d49-e063-6394a90ae0cf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
SOLUTION
Route
ORAL
Labeler
Mollec Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-18
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
Kosher Meds 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
42ad618b-d2e5-4c58-9407-386df4fe4004Available 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
82179-004-04Kosher Meds Childrens Allergy Relief118 mL in 1 BOTTLESOLUTION1182
82179-004-04Kosher Meds Childrens Allergy Relief1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82179-004KOSHER MEDS CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [MOLLEC INC]2Current NDC, 2 package rows20240517_42ad618b-d2e5-4c58-9407-386df4fe4004.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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
application number: M013
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
application number: M013
Pain Reliever, Caseys 4goodACETAMINOPHEN 500 MG, TABLETLil' Drug Store Products, Inc.039d2cf1-57f6-4d9d-e063-6394a90a54922024-12-16WarningsExact identifier
application number: M013
Extra Strength Headache, Caseys 4goodACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0425c6a8-a3ea-24ad-e063-6294a90ae15a2024-12-16WarningsExact identifier
application number: M013
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e75551-1e50-9896-e053-2a95a90aafd42024-12-14WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e5df0e-06d3-6f72-e053-2995a90a2d072024-12-14WarningsExact identifier
application number: M013
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLCb8ee568c-80cf-4e35-865e-35516bdab0fd2024-12-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.c0de0bd2-4868-46dc-a20f-3ca02caaa26b2024-12-11WarningsExact identifier
application number: M013
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
application number: M013
EXTRA STRENGTH Headache Relief geltabsACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.b432771a-4f7d-4d39-a038-d1561d8f67082024-12-11WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)223ffb2b-3ee5-4118-955b-bc4fa4e8a2e62024-12-10WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUNFIe689c9e3-dd4d-c646-e053-2a95a90a4b6a2024-12-09WarningsExact identifier
application number: M013
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART972f09a7-2aa1-4b1b-a6dc-2c4578a078032024-12-05WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6feff0a-3347-194d-e053-2a95a90acd202024-12-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN42ad618b-d2e5-4c58-9407-386df4fe40042
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD42ad618b-d2e5-4c58-9407-386df4fe40042
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY42ad618b-d2e5-4c58-9407-386df4fe40042
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY42ad618b-d2e5-4c58-9407-386df4fe40042
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY42ad618b-d2e5-4c58-9407-386df4fe40042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82179-004-04821790004041 BOTTLE in 1 CARTON (82179-004-04) / 118 mL in 1 BOTTLE1 bottle2024-04-18NoNoCurrent