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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41226-160-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41226-160-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41226-160-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41226-160-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41226-160-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41226-160-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41226-160-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41226-160-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41226-160-40	`0efc9e666f02…`	`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
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
bc019c9e-8fac-5fd3-e053-2a95a90a7ccd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
41226-160-01	2025-02-10	160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-40	2025-02-10	160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-42	2025-02-10	160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-01	2025-01-30	160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-40	2025-01-30	160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets
41226-160-42	2025-01-30	160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41226-160-01	ALLERGY	1 in 1 CARTON	TABLET, FILM COATED	1	4
41226-160-01	ALLERGY	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
41226-160-40	ALLERGY	400 in 1 BOTTLE	TABLET, FILM COATED	400	4
41226-160-40	ALLERGY	1 in 1 CARTON	TABLET, FILM COATED	1	4
41226-160-42	ALLERGY	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	4
41226-160-42	ALLERGY	1 in 1 CARTON	TABLET, FILM COATED	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41226-160	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [KROGER COMPANY]	3	Current NDC, Legacy NDC, 6 package rows	20250212_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 58 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Neighbor Pharmacy Pain Relief	ACETAMINOPHEN	Amerisource Bergen	5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1	2024-10-30	Warnings	Exact identifier application number: M013
Acetaminophen	PAIN RELIEVER	McKesson	9d620700-5d00-475f-e053-2995a90a9a3f	2024-10-28	Warnings	Exact identifier application number: M013
Junior Acetaminophen Ages 6-11	ACETAMINOPHEN	Chain Drug Consortium	d356bc9c-66f1-45c3-a455-98c0b8890f78	2024-10-28	Warnings	Exact identifier application number: M013
leader Acetaminophen	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	36bdcac9-eed4-40f9-a6f2-4c1e773a6b50	2024-10-25	Warnings	Exact identifier application number: M013
GOODYS PM	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	Medtech Products Inc.	db5d6c2b-688e-4e88-a42d-0fa2b0d8140b	2024-10-25	Warnings	Exact identifier application number: M013
Goodys Extra Strength	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	16d774cc-4247-4bf8-9b5a-c338ffebda3d	2024-10-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	PUBLIX SUPER MARKETS INC	9e77ab7a-07e8-42aa-e053-2995a90a0d0e	2024-10-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Kroger Company	5bfd9841-c781-43be-b823-d334893ae6ed	2024-10-24	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	H E B	add6952e-9dd5-487c-93e6-337e9d6a4872	2024-10-24	Warnings	Exact identifier application number: M013
Dye Free Pain Reliever Childrens	ACETAMINOPHEN	Safeway, Inc.	7d55cb42-295f-473a-941d-71825b44a3c0	2024-10-24	Warnings	Exact identifier application number: M013
rapid release pain relief	ACETAMINOPHEN	Publix Super Markets Inc	d0b34133-d69d-47db-bf51-be942769c612	2024-10-24	Warnings	Exact identifier application number: M013
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	00146b91-008d-4b16-95b0-6077f98821be	2024-10-24	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	9a20273e-a4d1-4c38-9efb-e6347f8dc14e	2024-10-24	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e221905b-a795-c067-e053-2a95a90a02e7	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e221bbce-83de-0f03-e053-2995a90abca5	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e231c2f6-927c-1ab0-e053-2995a90a6121	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e23703bb-6087-7985-e053-2995a90aa5ec	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e237550d-711d-5d87-e053-2995a90affce	2024-10-23	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	HARRIS TEETER	a6f15f71-1327-4b71-b9d6-e3e9f0243801	2024-10-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	43308b23-7d4f-4e4f-a497-af71920d86aa	2024-10-22	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	bc019c9e-8fac-5fd3-e053-2a95a90a7ccd	4
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	bc019c9e-8fac-5fd3-e053-2a95a90a7ccd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41226-160-01	41226016001	1 BOTTLE in 1 CARTON (41226-160-01) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-05-11	0000-00-00	No	No	Current
41226-160-40	41226016040	1 BOTTLE in 1 CARTON (41226-160-40) / 400 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-05-11	0000-00-00	No	No	Current
41226-160-42	41226016042	1 BLISTER PACK in 1 CARTON (41226-160-42) / 12 BLISTER PACK in 1 BLISTER PACK / 12 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2021-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets	Kroger Company \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2025-06-25	HUMAN OTC DRUG LABEL	4