FDA.reportPublic FDA data

KROGER Dye Free Childrens Allergy Relief

Product NDC
41226-710
Requested package NDC
41226-710-08
11-digit product format
412260710
Labeler code
41226
Product ID
41226-710_e6af3d28-a54b-4586-a758-ea04a09192a1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
KROGER COMPANY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-17
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
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
KROGER Dye Free Childrens Allergy Relief
Listing expiration
2027-12-31

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
2bea22e9-34b6-4961-94bb-5600dd90e891Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-710-08KROGER Dye Free Childrens Allergy Relief1 in 1 CARTONSYRUP13
41226-710-08KROGER Dye Free Childrens Allergy Relief236 mL in 1 BOTTLE, PLASTICSYRUP2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-710KROGER DYE FREE CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [KROGER COMPANY]2Current NDC, 2 package rows20240801_2bea22e9-34b6-4961-94bb-5600dd90e891.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 139 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Poly-Vent IRGUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.ce0d8c45-446a-4df4-a36b-5000ba69d30d2024-11-09WarningsExact identifier
application number: M012
basic care tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC306d5914-03ed-410a-9345-c54ba604e9912024-11-09WarningsExact identifier
application number: M012
care one nasal originalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companya0c35e06-c9e9-438e-8224-d4760b6e2aff2024-11-09WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company34174507-cf2e-4ed4-85ec-f915d4b910df2024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
application number: M012
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
application number: M012
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC2884d2dc-2d4a-4ca6-ab73-688a80b428eb2024-11-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/NightACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATEKenvue Brands LLC712ba011-79aa-469b-9f0f-04a0b4b705bd2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
application number: M012
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
application number: M012
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC1e528f78-0ced-4a06-935a-84056c9217272024-11-08WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC657a1e59-104c-4152-b2c9-00a8b82dc78e2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC47c61858-72ce-409b-a3af-a63620cf7d132024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCb8b75904-3806-4258-89c1-d6ff486ed41c2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC464de5de-0e7a-41d6-875f-dd0e5fe7893c2024-11-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2bea22e9-34b6-4961-94bb-5600dd90e8913
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2bea22e9-34b6-4961-94bb-5600dd90e8913
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2bea22e9-34b6-4961-94bb-5600dd90e8913
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2bea22e9-34b6-4961-94bb-5600dd90e8913
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2bea22e9-34b6-4961-94bb-5600dd90e8913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
41226-710-08412260710081 BOTTLE, PLASTIC in 1 CARTON (41226-710-08) / 236 mL in 1 BOTTLE, PLASTIC2024-06-17NoNoCurrent