Childrens Benadryl DYE-FREE ALLERGY

Product NDC: 50580-535
11-digit product format: 505800535
Labeler code: 50580
Product ID: 50580-535_27d44a57-0879-63ea-e063-6394a90ac4cf
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-07-01
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: 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 DYE-FREE ALLERGY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

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
1049906	Internal RxNorm lookup
1049908	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
10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
50580-535-01	2024-02-01	Children's Benadryl ® DYE-FREE ALLERGY
50580-535-08	2024-02-01	Children's Benadryl ® DYE-FREE ALLERGY
50580-535-01	2024-01-30	Children's Benadryl ® DYE-FREE ALLERGY
50580-535-08	2024-01-30	Children's Benadryl ® DYE-FREE ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-535-01	Childrens Benadryl DYE-FREE ALLERGY	118 mL in 1 BOTTLE	SOLUTION	118	10
50580-535-01	Childrens Benadryl DYE-FREE ALLERGY	1 in 1 CARTON	SOLUTION	1	10
50580-535-02	Childrens Benadryl DYE-FREE ALLERGY	1 in 1 CARTON	SOLUTION	1	10
50580-535-02	Childrens Benadryl DYE-FREE ALLERGY	2 in 1 PACKAGE	SOLUTION	2	10
50580-535-08	Childrens Benadryl DYE-FREE ALLERGY	236 mL in 1 BOTTLE	SOLUTION	236	10
50580-535-08	Childrens Benadryl DYE-FREE ALLERGY	1 in 1 CARTON	SOLUTION	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-535-01	ML - Milliliter	50580-535	e7122ba9-fb23-40f7-9eff-7348cc2a7935	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-535	CHILDRENS BENADRYL DYE-FREE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]	10	Current NDC, Legacy NDC, 6 package rows	20241204_10d478ff-ddc6-45da-87ff-cfe1b2b07a8e.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 133 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nasal Decongestant PE and Pain Relief Plus Mucus Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	31531f90-8933-46ab-b722-cb63e7738639	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f3ab4-5e10-3004-e053-2a95a90a0cb4	2024-12-03	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	2861b801-e778-822d-e063-6394a90aa1a8	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	fe0cf681-f42c-430c-8429-f7ba4bc5a976	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multisymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	0ea270b7-9c28-49fb-9615-c4afdbdbc8f1	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	0955d856-cc4e-4ef2-8bc0-1a632a5b5f79	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	40c9c90d-6c9e-40d0-921d-1fd34eff90bb	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3d068d30-9a00-49d7-bbe9-d6b53c19e86d	2024-12-02	Warnings	Exact identifier application number: M012
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	73d4fc82-8508-44f8-83ca-9f32c5cd847b	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	19898135-0f7b-45a5-a672-14c49fd21077	2024-12-02	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	bb72de5d-d3c0-42fc-ae52-a3ad95214af5	2024-12-02	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	a242e005-0330-4afb-83b8-13c7d56f5c6d	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	53b15e75-9efd-4b4b-834b-6e9f12c60108	2024-12-02	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Geri-Care Pharmaceutical Corp	ac8a14ac-7023-1e23-e053-2995a90aea3a	2024-11-28	Warnings	Exact identifier application number: M012
Childrens Benadryl DYE-FREE ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	2024-11-27	Warnings	Exact identifier application number: M012 ndc (product): 50580-535
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	2024-11-27	Warnings	Exact identifier application number: M012
Severe Sinus Congestion Allergy and Cough Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	36a4ec1f-50c3-4d61-ada9-987ccad3563c	2024-11-26	Warnings	Exact identifier application number: M012
Daytime Nighttime Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	177e3247-402d-98e4-e063-6294a90ae068	2024-11-26	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
1049908	Benadryl Children's Allergy 12.5 MG in 5 mL Oral Solution	PSN	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049908	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]	SBD	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049908	Benadryl 2.5 MG/ML Oral Solution	SY	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049908	Benadryl Children's Allergy 12.5 MG per 5 ML Oral Solution	SY	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-535-01	50580053501	1 BOTTLE in 1 CARTON (50580-535-01) / 118 mL in 1 BOTTLE	1 bottle	2015-12-01	0000-00-00	No	No	Current
50580-535-02	50580053502	2 CARTON in 1 PACKAGE (50580-535-02) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE	2 carton	2024-11-18		No	No	Current
50580-535-08	50580053508	1 BOTTLE in 1 CARTON (50580-535-08) / 236 mL in 1 BOTTLE	1 bottle	2022-06-16	0000-00-00	No	No	Current