FDA.reportPublic FDA data

ALLERGY

Product NDC
41226-160
11-digit product format
412260160
Labeler code
41226
Product ID
41226-160_3860490c-68ee-ea49-e063-6394a90af03a
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kroger Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-11
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41226-160-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41226-160-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41226-160-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41226-160-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41226-160-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41226-160-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41226-160-420efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41226-160-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41226-160-400efc9e666f02…f202fb6c5f17…

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
ALLERGY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc019c9e-8fac-5fd3-e053-2a95a90a7ccdAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
41226-160-012025-02-10160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-402025-02-10160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-422025-02-10160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-012025-01-30160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-402025-01-30160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-422025-01-30160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-160-01ALLERGY1 in 1 CARTONTABLET, FILM COATED14
41226-160-01ALLERGY100 in 1 BOTTLETABLET, FILM COATED1004
41226-160-40ALLERGY400 in 1 BOTTLETABLET, FILM COATED4004
41226-160-40ALLERGY1 in 1 CARTONTABLET, FILM COATED14
41226-160-42ALLERGY12 in 1 BLISTER PACKTABLET, FILM COATED124
41226-160-42ALLERGY1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-160ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [KROGER COMPANY]3Current NDC, Legacy NDC, 6 package rows20250212_bc019c9e-8fac-5fd3-e053-2a95a90a7ccd.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 55 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltda352f588-4a70-42b2-8f9c-a73a0629517d2024-11-25WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5c42dd28-820c-4cc5-9016-11ad5e5806162024-11-25WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.4518fe82-3ba8-4e9e-a036-776df7fb8d572024-11-21WarningsExact identifier
application number: M013
Family Wellness Pain RelieverASPIRINFAMILY WELLNESS SERVICES, INC.075e19f4-1a58-aedd-e063-6294a90af7082024-11-20WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
application number: M013
Temp XACETAMINOPHENOPMX Chula Vistafd2edc32-0351-c991-e053-6294a90ab4ce2024-11-15WarningsExact identifier
application number: M013
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
application number: M013
Walgreens Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreens667418fc-a3ab-cbc7-e053-2a91aa0a20232024-11-13WarningsExact identifier
application number: M013
Up and Up Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETarget Corporationa72eef45-b985-638a-e053-2995a90aa20a2024-11-13WarningsExact identifier
application number: M013
Signature Care Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATESafeway, Inc6e120024-475a-73af-e053-2a91aa0a42a62024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Kroger Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEKroger Company6d858b0e-a3c8-2686-e053-2991aa0acc062024-11-13WarningsExact identifier
application number: M013
TopCare Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETopco Associates LLC639f9d57-f26a-708a-e053-2a91aa0a69622024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company6418cde9-607b-4ca1-e053-2991aa0a91702024-11-13WarningsExact identifier
application number: M013
Bromo SeltzerASPIRIN, SODIUM BICARBONATE, CITRIC ACIDTower Laboratories Ltd8ff88ee1-e33e-4051-992f-24e2720c48ce2024-11-13WarningsExact identifier
application number: M013
Care One Original Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEFoodhold U.S.A.8f662c51-d2fa-6458-e053-2995a90ac6fd2024-11-13WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefAPIRIN, CITRIC ACID, SODIUM BICARBONATETower Laboratories Ltd43c7f435-735c-3fab-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
DG Health Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDOLGENCORP, INC8f1343d5-2884-3a14-e053-2a95a90a2f902024-11-13WarningsExact identifier
application number: M013
Good Sense Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEGood Sensecd25b0c3-0134-beef-e053-2a95a90a092b2024-11-13WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDiscount Drug Mart, Inc8bc65603-1dbf-30ab-e053-2995a90a7c152024-11-13WarningsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Company8aab905b-5fe7-dddb-e053-2995a90a6c6f2024-11-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNbc019c9e-8fac-5fd3-e053-2a95a90a7ccd4
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDbc019c9e-8fac-5fd3-e053-2a95a90a7ccd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-160-01412260160011 BOTTLE in 1 CARTON (41226-160-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-110000-00-00NoNoCurrent
41226-160-40412260160401 BOTTLE in 1 CARTON (41226-160-40) / 400 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-110000-00-00NoNoCurrent
41226-160-42412260160421 BLISTER PACK in 1 CARTON (41226-160-42) / 12 BLISTER PACK in 1 BLISTER PACK / 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-05-110000-00-00NoNoCurrent