Childrens Metapp Daytime

Product NDC: 53041-577
11-digit product format: 530410577
Labeler code: 53041
Product ID: 53041-577_985528fa-a496-4fe2-b7ae-0d894b8e26b1
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Guardian Drug Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-06-06
Substance: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [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 Metapp Daytime
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMPHENIRAMINE MALEATE	1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IXA7C9ZN03	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090463	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
40565500-944b-47f2-8563-5df05469e418	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53041-577-03	Childrens Metapp Daytime	1 in 1 CARTON	LIQUID	1		4
53041-577-03	Childrens Metapp Daytime	118 mL in 1 BOTTLE	LIQUID	118		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53041-577	CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]	4	Current NDC, Legacy NDC, 2 package rows	20241220_40565500-944b-47f2-8563-5df05469e418.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 154 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	a1103cd8-344b-4a65-8a60-3c7be86d01a6	2024-09-11	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	276d7d3c-c4a7-4754-8845-c38f85aac5f7	2024-09-08	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479	2024-09-08	Warnings	Exact identifier application number: M012
equate nasal original	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	7e40c9b8-e0b5-448a-a674-72388fbab189	2024-09-08	Warnings	Exact identifier application number: M012
Anefrin Nasal Original	OXYMETAZOLINE HYDROCHLORIDE	Walgreen Company	85b442dc-1703-4fef-948a-fad7cbe9f224	2024-09-07	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	Warnings	Exact identifier application number: M012
Benadryl Allergy EXTRA STRENGTH	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	dd0a8069-18d8-5696-e053-2995a90a2f22	2024-09-06	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	PAI Holdings, LLC	88d0994c-4270-4408-8837-bd97510b2118	2024-09-06	Warnings	Exact identifier application number: M012
QCH Maximum Strength Mucus Relief 617	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	a1c5c15e-0f3a-47d3-b9ed-1e0018417514	2024-09-06	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime Soft Chews	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2024-09-05	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	344282fc-3bd1-4f49-9bd1-08c5a58d1f73	2024-09-05	Warnings	Exact identifier application number: M012
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	95ef1819-edc3-4dda-8514-85b61538cc72	2024-09-04	Warnings	Exact identifier application number: M012
Up and up nasal	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	0c246c11-eadd-4ac6-bd58-5fdb151e06d6	2024-09-04	Warnings	Exact identifier application number: M012
Exchange Select Nasal	OXYMETAZOLINE HYDROCHLORIDE	Army & Air Force Exchange Service	aafa9163-f08e-48c9-9ca1-7b72f67d007d	2024-08-31	Warnings	Exact identifier application number: M012
nasal 12 hour	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	e9ee03db-a070-4c2b-ac61-7fd22bab2795	2024-08-31	Warnings	Exact identifier application number: M012
dg health nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	42b58928-e8e5-49e4-b49e-498d77d64fcd	2024-08-28	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Kroger Company	0a24d98a-5950-49de-8b77-ea880b08d2c5	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	96e018e2-e0b5-4802-a4a1-73a73d574082	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HCL	Topco Associates LLC	b5434599-5485-4949-9d76-b1ef3ad17c1a	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	b15eb271-7842-495b-aa0f-9b20def86dc1	2024-08-28	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	40565500-944b-47f2-8563-5df05469e418	4
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	40565500-944b-47f2-8563-5df05469e418	4
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	40565500-944b-47f2-8563-5df05469e418	4
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	40565500-944b-47f2-8563-5df05469e418	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53041-577-03	53041057703	1 BOTTLE in 1 CARTON (53041-577-03) / 118 mL in 1 BOTTLE	1 bottle	2012-06-06	0000-00-00	No	No	Current