Guaifenesin DM

Product NDC: 43063-801
11-digit product format: 430630801
Labeler code: 43063
Product ID: 43063-801_06c3176d-e6f9-4231-e063-6394a90a694b
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-04-02
Marketing end: 2027-11-30
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 400; 20 mg/1; mg/1
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
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 DM

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	400 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/1

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
1147685	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
ac8c0c15-b305-47f2-8712-e4b53636f7fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43063-801-30	Guaifenesin DM	30 in 1 BOTTLE, PLASTIC	TABLET	30	9
43063-801-60	Guaifenesin DM	60 in 1 BOTTLE, PLASTIC	TABLET	60	9
43063-801-90	Guaifenesin DM	90 in 1 BOTTLE, PLASTIC	TABLET	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-801-30	EA - Each	43063-801	3c014083-7e0c-4bf5-8cde-bdbfddb3add1	1	2023-03-13
43063-801-60	EA - Each	43063-801	d83d21cb-25be-4d0a-b0e1-2787c8e4d0c9	1	2018-01-12
43063-801-90	EA - Each	43063-801	0f54a697-5994-450c-abb2-d643ac2833f3	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-801	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20231003_ac8c0c15-b305-47f2-8712-e4b53636f7fa.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 54 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	1d6c23d7-d1dc-4cba-8600-5762c18a0e27	2026-01-29	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Belmora LLC	3622e072-2784-c57e-e063-6394a90a8217	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M012
Night Time Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	e7dd763b-3005-4723-933b-171eb772afee	2026-01-29	Warnings	Exact identifier application number: M012
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	24bc9ae6-8e8f-c0a0-e063-6394a90a407f	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	229d1939-84a9-f18e-e063-6394a90aba30	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1fcbafaa-c871-db6d-e063-6394a90aab5e	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1f7a6375-ab66-9782-e063-6394a90a99f3	2026-01-28	Warnings	Exact identifier application number: M012
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	4970b8bc-3c7b-4b8a-e063-6294a90a7f1b	2026-01-28	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	fe3e74ba-31d9-4d50-ab61-ffb6aaa66085	2026-01-28	Warnings	Exact identifier application number: M012
Leader Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. dba Leader	9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5	2026-01-28	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	93d5b1db-e9ad-4a6a-b869-fd0d1a11df02	2026-01-27	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	53a3e6a7-d625-4393-95eb-bb6f86e86cc1	2026-01-27	Warnings	Exact identifier application number: M012
Dextromethorphan Hbr,Guaifenesin	DEXTROMETHORPHAN HBR,GUAIFENESIN	SOFTGEL HEALTHCARE PRIVATE LIMITED	2fbbfc7c-81a9-b647-e063-6394a90a55ac	2026-01-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	32074a31-326b-4aaf-e063-6394a90a0d40	2026-01-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	335b6ddd-fdc8-1120-e063-6394a90add41	2026-01-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	37e8ccd5-6be1-9aca-e063-6394a90a5263	2026-01-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	SOFTGEL HEALTHCARE PRIVATE LIMITED	2f7f078e-de04-9d53-e063-6394a90a409f	2026-01-27	Warnings	Exact identifier application number: M012
Sunscreen SPF50	NON NANO ZINC OXIDE	SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI	c5d52f13-a649-9579-e053-2a95a90a062c	2026-01-27	Warnings	Exact identifier application number: M012
XL-3 Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Rnv LLC	03210929-331e-462d-b566-4e1865f52246	2026-01-27	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Rnv LLC	2381ff41-4584-4b38-839f-f94e733f5bf2	2026-01-27	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
1147685	dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet	PSN	ac8c0c15-b305-47f2-8712-e4b53636f7fa	9
1147685	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD	ac8c0c15-b305-47f2-8712-e4b53636f7fa	9
1147685	guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet	SY	ac8c0c15-b305-47f2-8712-e4b53636f7fa	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-801-30	43063080130	30 TABLET in 1 BOTTLE, PLASTIC (43063-801-30)	30 tablet	2018-04-02	2027-11-30	No	No	Historical
43063-801-60	43063080160	60 TABLET in 1 BOTTLE, PLASTIC (43063-801-60)	60 tablet	2018-04-02	2027-11-30	No	No	Current
43063-801-90	43063080190	90 TABLET in 1 BOTTLE, PLASTIC (43063-801-90)	90 tablet	2018-04-02	2027-11-30	No	No	Current