Childrens Allergy

Product NDC: 53942-505
11-digit product format: 539420505
Labeler code: 53942
Product ID: 53942-505_d2d346ad-05dc-4c5a-9cb0-559434b62f97
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: DeMoulas Market Basket
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-09-11
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: 2027-12-31
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 Allergy
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049906	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
fd04fb94-f581-4ca2-b7ac-20359093863e	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53942-505-24	Childrens Allergy	118 mL in 1 BOTTLE	LIQUID	118		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53942-505	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]	3	Current NDC, Legacy NDC, 1 package rows	20231230_fd04fb94-f581-4ca2-b7ac-20359093863e.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 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motion Sickness Relief	DIMENHYDRINATE 50 MG	TARGET CORPORATION	28586e9b-01e3-0b88-e063-6394a90af7e0	2025-01-29	Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5MG	Ulai Health LLC	d304e205-85fa-494a-9a68-ae6855b139b1	2025-01-20	Warnings	Exact identifier application number: M009
Meclizine HCL 12.5 mg	MECLIZINE HCL 12.5 MG	Reliable 1 Laboratories LLC	32832b0f-0b38-27ce-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine HCL 25 mg	MECLIZINE HCL	Reliable 1 Laboratories LLC	32bdd802-16b0-184d-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	e4d785a7-a688-3acb-e053-2a95a90a6d2e	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	ed43bf21-f3da-245c-e053-2995a90a504c	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5 MG	RUGBY LABORATORIES	8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35	2024-12-20	Warnings	Exact identifier application number: M009
Meclizine	MECLIZINE HYDROCHLORIDE	Advanced Rx LLC	b0a2a1f7-354e-48bd-9e98-9207bf9f53fd	2024-11-27	Warnings	Exact identifier application number: M009
Dramamine, TRAVEL BASIX	DIMENHYDRINATE	Lil' Drug Store Products, Inc.	960a642b-ee7c-4e92-9b5f-930425682dac	2024-11-26	Warnings	Exact identifier application number: M009
Dramamine Less Drowsy, Lil Drug Store	MECLAZINE HYDROCHLORIDE TABLET	Lil' Drug Store Products, Inc.	275b3377-9280-c12c-e063-6294a90a5421	2024-11-20	Warnings	Exact identifier application number: M009
PhysiciansCare Motion Sickness	MECLIZINE HCL	Acme United Corporation	c4d3ea22-7c22-7311-e053-2a95a90a779c	2024-11-12	Warnings	Exact identifier application number: M009
DRAMAMINE - N	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	7fec7791-c242-4e43-8184-32820e657afb	2024-10-25	Warnings	Exact identifier application number: M009
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	f8cf751a-9f19-4744-a350-cd22303435ee	2024-10-25	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d955f612-1265-f1be-e053-2995a90a5345	2024-07-18	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	199ae195-4556-ee88-e063-6394a90a40d4	2024-06-10	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d941705f-12a1-4757-e053-2995a90ad3fa	2024-05-13	Warnings	Exact identifier application number: M009
Kids Gravol Chewables Motion Sickness Dimenhydrinate	DIMENHYDRINATE	Church & Dwight Co., Inc.	cf6de950-a157-4be2-a302-0dc19511d2f2	2024-03-01	Warnings	Exact identifier application number: M009
Gravol Chewables Motion Sickness Dimenhydrinate	DIMENHYDRINATE	Church & Dwight Co., Inc.	de5249f7-79fc-4f3c-965a-1e8ec978a0b7	2024-03-01	Warnings	Exact identifier application number: M009
Meclizine HCl	MECLIZINE HYDROCHLORIDE CHEWABLE	BluePoint Laboratories	d9cc2705-9dcc-0a73-e053-2995a90aafe6	2024-02-21	Warnings	Exact identifier application number: M009
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DeMoulas Market Basket	fd04fb94-f581-4ca2-b7ac-20359093863e	2023-12-29	Warnings	Exact identifier application number: M009 ndc (product): 53942-505

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
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	fd04fb94-f581-4ca2-b7ac-20359093863e	3
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	fd04fb94-f581-4ca2-b7ac-20359093863e	3
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	fd04fb94-f581-4ca2-b7ac-20359093863e	3
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	fd04fb94-f581-4ca2-b7ac-20359093863e	3
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	fd04fb94-f581-4ca2-b7ac-20359093863e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53942-505-24	53942050524	118 mL in 1 BOTTLE (53942-505-24)	118 ml	2012-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Allergy - 505	DeMoulas Market Basket \| AptaPharma Inc.	2023-12-29	HUMAN OTC DRUG LABEL	3