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 81 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dec468-fbb2-3489-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	d7711cd6-5058-548d-e053-2a95a90ac54d	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	a2f0285b-8550-fd26-e053-2995a90ab615	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	f6c73f61-f4fc-377f-e053-6294a90a3797	2025-12-04	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Bayer Healthcare LLC.	a32e2a5e-9aa0-4e7c-e053-2995a90a3190	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e2877488-3539-cba2-e053-2995a90a6005	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChews	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	14951faa-9476-6f29-e063-6394a90a14c7	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels	ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION	Bayer HealthCare LLC.	0c120569-622d-3a23-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChews	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	149330be-24bd-b4a4-e063-6394a90a9007	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN	Bayer HealthCare LLC.	5278a128-41ec-4494-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	53188c41-3f13-311b-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	75894849-a0ba-57be-e053-2a91aa0a049a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	531ab703-179a-70ad-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	7588ea67-68a9-4dc0-e053-2991aa0aa471	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Cough	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	75862805-2cfe-fb45-e053-2991aa0a1403	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5172dc01-4e7f-3307-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	20ae92d9-fbc6-5b7a-e063-6294a90a15c3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51c44970-06e5-082e-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	54236151-37db-0b5a-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	52542774-fd05-640c-e054-00144ff8d46c	2025-12-04	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