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 149 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Retail Business Services , LLC.	8bc68a71-62c5-a04f-e053-2995a90a92fd	2024-10-15	Warnings	Exact identifier application number: M012
COLD FLU AND SORE THROAT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f960566-0158-6637-e053-2995a90a9c4a	2024-10-15	Warnings	Exact identifier application number: M012
HEAD CONGESTION PLUS FLU SEVERE PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	e65cf21d-3d69-a53e-e053-2a95a90a1c83	2024-10-15	Warnings	Exact identifier application number: M012
night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H E B	49f5f4d3-556c-4ee3-b5cd-5331dd434bb9	2024-10-15	Warnings	Exact identifier application number: M012
Mielim y mas	DEXTROMETHORPHAN	Efficient Laboratories Inc.	711d1dae-3af4-46af-a3a8-cd827356a81a	2024-10-14	Warnings	Exact identifier application number: M012
Tukol Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	27ab3d86-e960-4d83-aad1-d50d2c8e02a9	2024-10-14	Warnings	Exact identifier application number: M012
HealthWise Chest Rub Lavender	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	2472ce85-c701-4fcd-e063-6394a90a2765	2024-10-14	Warnings	Exact identifier application number: M012
HealthWise Chest Rub Lemon	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	24740d5a-aba1-0bd4-e063-6394a90ab2ca	2024-10-14	Warnings	Exact identifier application number: M012
Childrens Plus Cough and Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd43	2024-10-14	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN	Haleon US Holdings LLC	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	2024-10-14	Warnings	Exact identifier application number: M012
Cough Relief Adult	DEXTROMETHORPHAN HBR	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f5c57b32-69cb-469e-ad2d-64c00b5e66dc	2024-10-14	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Publix Super Markets Inc	94c21df5-c631-4748-a833-288b2298055c	2024-10-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	8eab9d79-69c1-44b8-9145-a7ebd887d54d	2024-10-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	e4963eec-fb4a-425c-be19-f514b4f10a7f	2024-10-11	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	1b4e87f8-3f9e-4865-9128-527d2d621593	2024-10-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	ff433512-55b7-4fc9-8a55-aff5cbb749ef	2024-10-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3170354a-4752-49a0-97ed-3d9db266a059	2024-10-11	Warnings	Exact identifier application number: M012
Tukol Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	235a6d2b-7302-410c-be35-4d5ff7bbdfce	2024-10-11	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS Pharmacy	6c7b0ea6-bff9-4fd2-9e00-64015c326ee8	2024-10-11	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Meijer Distribution Inc	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	2024-10-11	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