Guaifenesin and Dextromethorphan

Product NDC: 0904-7512
11-digit product format: 009047512
Labeler code: 0904
Product ID: 0904-7512_7a9d1e3e-d1ad-4b40-9f77-6df15fecacc2
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan
Dosage form: SYRUP
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-02-10
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 100; 10 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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: Guaifenesin and Dextromethorphan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	100 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
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
996520	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
97b137c9-0bec-409a-91f7-e298c296578b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7512-41	Guaifenesin and Dextromethorphan	5 mL in 1 CUP, UNIT-DOSE	SYRUP	5	4
0904-7512-70	Guaifenesin and Dextromethorphan	10 in 1 CASE	SYRUP	10	4
0904-7512-70	Guaifenesin and Dextromethorphan	10 in 1 TRAY	SYRUP	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7512-41	ML - Milliliter	0904-7512	9cdd17b4-83f5-4ebf-b719-12a23d2030e0	1	2025-03-04
0904-7512-70	ML - Milliliter	0904-7512	367db5fb-c75b-41e4-8c2b-f37c3d5ae9cf	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7512	GUAIFENESIN AND DEXTROMETHORPHAN SYRUP [MAJOR PHARMACEUTICALS]	4	Current NDC, 3 package rows	20250211_97b137c9-0bec-409a-91f7-e298c296578b.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 26 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	WALMART INC.	321430a5-11c9-4d33-8638-5149f601f1bb	2026-05-22	Warnings	Exact identifier application number: M012
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp Inc	ddcc1e78-4ea8-4489-88e7-86ff46016464	2026-05-21	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e	2026-05-21	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	525467fb-510d-0b4b-e063-6294a90acd36	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4cee80e5-e412-e832-e063-6394a90aeb90	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Reckitt Benckiser LLC	4a9464cf-0c77-23d0-e063-6394a90a62f1	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4ceda68e-c7ce-eb87-e063-6394a90a8ded	2026-05-21	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	5258ea3f-87f1-7f86-e063-6394a90ab82f	2026-05-21	Warnings	Exact identifier application number: M012
RELIABLE-1 ANTI DRIP PUMP MIST	OXYMETAZOLINE HYDROCHLORIDE	Reliable 1 Laboratories LLC	7df9905d-09aa-4c84-8b6f-6e5ed90df0da	2026-05-21	Warnings	Exact identifier application number: M012
daytime nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	80abb6b8-b0d5-4f19-8588-50b8717510bb	2026-05-21	Warnings	Exact identifier application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEF	OXYMETAZOLINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES INC	27163169-54d0-4b6e-94cd-721b29b18249	2026-05-20	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Fast	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5241b11a-72c8-5e67-e063-6394a90a4353	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	50b140ad-aba2-ce6b-e063-6294a90ae2f8	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4bae240c-70ce-e9c2-e063-6394a90a5f3d	2026-05-20	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	85f7d60b-32ec-4ec2-86ec-f677093bce1d	2026-05-20	Warnings	Exact identifier application number: M012
Chloraseptic Nighttime Sore Throat Hot Relief	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	9c13c052-a5d1-43d2-8d29-4ea011a971ac	2026-05-20	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	a0bff310-2d35-4a18-815b-8386e44730a2	2026-05-19	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	61a1beb3-decf-4c8d-a402-93a02ec40a43	2026-05-19	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	52291746-2bbf-8f3f-e063-6294a90adcfc	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCI	Reckitt Benckiser LLC	fdb70793-5dd1-0455-e053-6394a90ac621	2026-05-19	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	97b137c9-0bec-409a-91f7-e298c296578b	4
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	97b137c9-0bec-409a-91f7-e298c296578b	4
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	97b137c9-0bec-409a-91f7-e298c296578b	4
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	97b137c9-0bec-409a-91f7-e298c296578b	4
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	97b137c9-0bec-409a-91f7-e298c296578b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7512-41	00904751241	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
0904-7512-70	00904751270	10 TRAY in 1 CASE (0904-7512-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7512-41)	10 tray	2025-02-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin Syrup and Dextromethorphan Syrup Expectorant/Cough Suppressant	Major Pharmaceuticals	2025-01-29	HUMAN OTC DRUG LABEL	4