Childrens Giltuss Honey DM Cough

Product NDC: 58552-144
11-digit product format: 585520144
Labeler code: 58552
Product ID: 58552-144_40b8c1dc-4837-be7b-e063-6394a90a26f8
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr
Dosage form: SOLUTION
Route: ORAL
Labeler: Gil Pharmaceutical Corp
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-22
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 15 mg/5mL
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Giltuss Honey DM Cough
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090496	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
a8c5027f-9701-fb07-e053-2a95a90a6029	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-01-30	Giltuss Honey DM, Childrens
2022-01-30	Giltuss Honey DM, Childrens
2022-01-28	Giltuss Honey DM, Childrens
2022-01-28	Giltuss Honey DM, Childrens

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58552-144-04	Childrens Giltuss Honey DM Cough	1 in 1 CARTON	SOLUTION	1		6
58552-144-04	Childrens Giltuss Honey DM Cough	118 mL in 1 BOTTLE	SOLUTION	118		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58552-144-04	ML - Milliliter	58552-144	ab3ef6c4-661a-4458-8904-6e3c913b5ab5	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58552-144	CHILDRENS GILTUSS HONEY DM COUGH (DEXTROMETHORPHAN HBR) SOLUTION [GIL PHARMACEUTICAL CORP]	5	Current NDC, Legacy NDC, 2 package rows	20241027_a8c5027f-9701-fb07-e053-2a95a90a6029.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 61 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Complete Allergy Medicine	DIPHENHYDRAMINE HCL	Salado Sales, Inc.	c0f5c8ca-b187-40bf-9245-6a29f1c32c97	2026-01-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	c5776b1e-9f72-4a6a-9961-8ac8e05b3249	2026-01-06	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	b9215a5e-3be8-44fd-9189-50dab760869c	2026-01-06	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Major Pharmaceuticals	f81efbf4-204b-45be-ae32-910d9e4ae4aa	2026-01-06	Warnings	Exact identifier application number: M012
SINUS AND NASAL DECONGESTANT	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d7646859-f996-46cd-a0b9-56b860f60901	2026-01-05	Warnings	Exact identifier application number: M012
HyVee Cough Drops Honey Lemon	MENTHOL	HY-VEE, INC	47a71cdf-856d-9ecd-e063-6294a90a70c6	2026-01-05	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Oncor Pharmaceuticals	fd35036c-b722-48a3-85fd-60471beb6e74	2026-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals,Inc.	3c323dc8-f734-b44c-e063-6394a90a6184	2026-01-05	Warnings	Exact identifier application number: M012
Congestion and Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	f43d97b1-aeb9-4ca5-8909-b28e7bf764f5	2026-01-05	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	6bd2b8fd-2023-413b-8988-a47d2058dc85	2026-01-05	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	WinCo Foods, LLC	4c1046df-53a6-4219-83ac-bbf5cf4db9c8	2026-01-05	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	80323208-9ba5-432b-a8a0-0c0b51e67145	2026-01-05	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain PE Maximum Strength	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Rite Aid Corporation	347868e4-0182-4e16-895c-ec269895c57c	2026-01-02	Warnings	Exact identifier application number: M012
HyVee Cough Drops Cherry	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	c5b11a9c-6d93-4772-93c2-1ef5c5647016	2026-01-02	Warnings	Exact identifier application number: M012
HyVee Cough Drops Honey Lemon	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	fae96736-1453-42fe-8158-cde770b23165	2026-01-02	Warnings	Exact identifier application number: M012
HyVee Cough Drops Menthol	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd	2026-01-02	Warnings	Exact identifier application number: M012
Reliable-1 Tussin	GUAIFENESIN	RELIABLE 1 LABORATORIES LLC	2a33ff82-49df-7aaa-e063-6294a90a1281	2026-01-02	Warnings	Exact identifier application number: M012
Tussin DMMax	DEXTROMETHORPHAN HBR, GUAIFENESIN	RELIABLE 1 LABORATORIES LLC	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa	2026-01-02	Warnings	Exact identifier application number: M012
Severe Sinus Pain and Congestion Daytime	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7	2026-01-02	Warnings	Exact identifier application number: M012
NUVALU VAPORIZING CHEST RUB	CAMPHOR, EUCALYPTUS OIL, MENTHOL	JC SALES	490b2d1e-3a1d-1a52-e063-6394a90a00ba	2026-01-01	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090496	dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	a8c5027f-9701-fb07-e053-2a95a90a6029	6
1090496	dextromethorphan hydrobromide 3 MG/ML Oral Solution	SCD	a8c5027f-9701-fb07-e053-2a95a90a6029	6
1090496	dextromethorphan hydrobromide 15 MG per 5 ML Oral Solution	SY	a8c5027f-9701-fb07-e053-2a95a90a6029	6
1090496	dextromethorphan hydrobromide 30 MG per 10 ML Oral Solution	SY	a8c5027f-9701-fb07-e053-2a95a90a6029	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58552-144-04	58552014404	1 BOTTLE in 1 CARTON (58552-144-04) / 118 mL in 1 BOTTLE	1 bottle	2020-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Giltuss Honey DM, Childrens	Gil Pharmaceutical Corp \| Dextrum Laboratories Inc	2025-10-09	HUMAN OTC DRUG LABEL	6