Childrens Benadryl Chewables

Product NDC: 50580-232
11-digit product format: 505800232
Labeler code: 50580
Product ID: 50580-232_215db1b4-b8fb-90be-e063-6294a90a6353
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-07-11
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 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

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: Childrens Benadryl Chewables
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049900	Internal RxNorm lookup
1049901	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
b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-232-01	2024-02-01	C162847	48780-1	1030e364-fd97-111a-e063-dadaa90a10e2	Children's Benadryl ® Chewables
50580-232-01	2024-01-30	C162847	48780-1	1030e364-fd97-111a-e063-dadaa90a10e2	Children's Benadryl ® Chewables

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-232-01	Childrens Benadryl Chewables	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10		7
50580-232-01	Childrens Benadryl Chewables	2 in 1 CARTON	TABLET, CHEWABLE	2		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-232-01	EA - Each	50580-232	4445c856-b1ee-4622-8a5b-446f41f62300	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-232	CHILDRENS BENADRYL CHEWABLES (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241109_b08f71d8-a06c-41ba-8ed1-fbc41dbc1919.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 160 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, LLC	71445443-34bd-4d8c-b9c8-e7c3b8d4c832	2024-07-19	Warnings	Exact identifier application number: M012
basic care childrens allergy relief	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	75b9ee90-ad26-433e-8b90-97441b8d1e15	2024-07-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC	9b74dd00-8f84-4fce-b5ea-df886b595326	2024-07-18	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	4872dfdd-0df6-47ae-87f2-8049191cd482	2024-07-18	Warnings	Exact identifier application number: M012
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b05acd16-21cb-4ee0-afa0-8f7d59166435	2024-07-18	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	cc6e4e26-84f5-4003-b1eb-f0e06d3e294e	2024-07-18	Warnings	Exact identifier application number: M012
childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	10ebc7f8-dc8a-4640-8f87-d0d073998fd5	2024-07-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	b173cc2c-7c4c-4f9e-a920-c71bc256ec1e	2024-07-18	Warnings	Exact identifier application number: M012
ALLERGY	CHLORPHENIRAMINE MALEATE	A-S Medication Solutions	b199b5ee-fff3-4746-be68-a04060586f8e	2024-07-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	H E B	2d1715b3-b1cf-455d-9909-f6d58c97db40	2024-07-18	Warnings	Exact identifier application number: M012
careone allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	ed4038fc-ab39-4567-9961-2b390b91b126	2024-07-17	Warnings	Exact identifier application number: M012
Topcare childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	6b784cde-3152-4421-a825-dd1fc601aa7a	2024-07-17	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	4c6b6379-3a7f-4507-a792-7b69a7f3ba82	2024-07-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	04defcf6-e20e-402b-b725-d9394a0146b1	2024-07-16	Warnings	Exact identifier application number: M012
basic care allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	7d237d37-21c7-476d-a8b7-d91ea1b472ee	2024-07-16	Warnings	Exact identifier application number: M012
Berkley and Jensen Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC	b52fc311-8853-4116-941b-8be35456abba	2024-07-16	Warnings	Exact identifier application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	0b9a4438-7d13-484c-a614-2dedc24974dc	2024-07-16	Warnings	Exact identifier application number: M012
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Publix Super Markets Inc	23a98385-28cc-4fac-8c87-b3ced8106532	2024-07-16	Warnings	Exact identifier application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe	0.05% OXYMETAZOLINE	Walgreens Company	aad01028-cbe0-4c10-adbc-d157bfa5af09	2024-07-16	Warnings	Exact identifier application number: M012
Basic Care severe cold and cough	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	924bf427-b054-46af-b341-ff162946cd58	2024-07-15	Warnings	Exact identifier application number: M012

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
1049901	Benadryl Allergy 12.5 MG Chewable Tablet	PSN	b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	7
1049900	diphenhydrAMINE HCl 12.5 MG Chewable Tablet	PSN	b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	7
1049901	diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]	SBD	b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	7
1049900	diphenhydramine hydrochloride 12.5 MG Chewable Tablet	SCD	b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	7
1049901	Benadryl 12.5 MG Chewable Tablet	SY	b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-232-01	50580023201	2 BLISTER PACK in 1 CARTON (50580-232-01) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	2 blister pack	2016-07-11	0000-00-00	No	No	Current