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 16 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain Relief Dye freeACTEMINOPHENBETTER LIVING BRANDS LLC.41f504d1-29c4-f075-e063-6394a90ad64c2026-04-11WarningsExact identifier
application number: M013
Dr. Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4f1e1f1a-44f4-2356-e063-6294a90a8cdd2026-04-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAkron Pharma Inc.e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed2026-04-10WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.28413cb3-22c4-40e2-ad6b-42beb438dea32026-04-10WarningsExact identifier
application number: M013
Pain Reliever ChildrensACETAMINOPHENH E B7e43de11-d20b-4920-a04d-3c1b5d35e0052026-04-09WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINNavajo Manufacturing Company Inc.f6f2ce71-5728-aefb-e053-6394a90a20e42026-04-08WarningsExact identifier
application number: M013
MidolACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATENavajo Manufacturing Company Inc.cabd10f2-a91e-4406-9249-915e306c867b2026-04-08WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc3730ee46-b241-44eb-94fa-52b9d12a9c352026-04-08WarningsExact identifier
application number: M013
AspirinASPIRINWalgreen Company82cc404b-fcf5-4e48-ab1a-09d8c47f9e042026-04-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC1b164780-ec84-4187-8afa-6f8a0da550fc2026-04-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreens6e7475e2-81a9-43b5-9b81-b58ab761a6f42026-04-07WarningsExact identifier
application number: M013
Pain Relief Aspirin Low DoseASPIRINRite Aid Corporation503408ed-e799-48a0-8d38-3034f4a0ead52026-04-02WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINLidl US LLC468f4a2f-60f7-4808-95d7-a00be1bb112f2026-04-02WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENGrocery Outlet, Inc.44de6f5a-0b5c-6c28-e063-6394a90a7e0b2026-04-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICE26ae0d0a-34c0-4d16-951a-8d5a463c808b2026-04-02WarningsExact identifier
application number: M013
Pain Reliever plus Sleep Aid NightTimeACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger Company286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d02026-04-02WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINCOSTCO WHOLESALE CORPORATIONc8a8986b-1ab4-9da0-71da-42595db08b442026-04-02WarningsExact 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