FDA.reportPublic FDA data

KROGER Dye Free Childrens Allergy Relief

Product NDC
41226-710
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 22 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks NyQuil Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyd1657403-b953-4db1-9a86-343e9e769a1a2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company04dc3835-64be-d9e4-e063-6394a90a85992026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company1a01b294-a5ee-ab35-e063-6394a90a4a1a2026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil ALLERGYDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2f9b3bbb-4494-065d-e063-6294a90afcd22026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil Kids ALLERGYDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2f9a6d65-f849-af0a-e063-6394a90ae4352026-06-22WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company1a01d4f7-37ed-bb92-e063-6294a90a208c2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company326ed27d-cbfa-5513-e063-6394a90a41bf2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil Kids and Vicks NyQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2d430264-074d-fb22-e063-6294a90a57f62026-06-22WarningsExact identifier
application number: M012
DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINThe Procter & Gamble Manufacturing Companyef6e8503-d268-291b-e053-2995a90aec8f2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company4147ff00-8e21-7335-e054-00144ff88e882026-06-22WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGEN51021c69-d92b-0504-e063-6294a90a94e72026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil SINUS PAIN and HEADACHEACETAMINOPHEN, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company4c4ca296-ea6c-1f19-e063-6294a90a81612026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company32bea3dc-9889-22dd-e063-6394a90afa1b2026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
application number: M012
Sinus and Congestion Non-DrowsyPSEUDOEPHEDRINE HCLWal-Mart Stores Inccbdac7ad-3904-4a85-91a9-863f6f06503d2026-06-22WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
application number: M012
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
application number: M012
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsExact 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