Maximum Strength Guaifenesin DM

Product NDC: 0536-1213
11-digit product format: 005361213
Labeler code: 0536
Product ID: 0536-1213_74767680-e4e7-4ba6-8d45-a01cd0471317
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Dextromethorphan HBr
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Rugby Laboratories
Application: ANDA209692
Marketing category: ANDA
Marketing start: 2018-11-05
Marketing end: 2026-09-28
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 60; 1200 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL			2018-11-01
A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-11-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL			2018-11-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-11-01	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	3850544d-0d25-429e-98a9-5c4ad6cfd222	2026-07-14	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	6d454e89-59ce-40dc-b0d2-3330a7df519f	2026-04-15	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	344de7bb-de3b-4c15-a920-72d94e5e0e9f	2026-03-18	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	CVS Pharmacy	59c338a0-8dc9-43a7-b8df-c26ae475def3	2026-03-18	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	e24fd894-5dee-4f46-aafa-fbf9f0b166fd	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Maximum Strength Guaifenesin DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rugby Laboratories	2c9515f8-3120-4dbb-a7fc-d89fc5727148	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692 ndc (product): 0536-1213
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rugby Laboratories	69cd399a-0103-4543-bb06-c7cccffe9cc4	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	P & L Development, LLC	a397799d-46a6-447b-9498-17436d218e29	2026-01-28	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2426bf76-19bf-4bfd-8f9e-3b348e4b5641	2025-11-11	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	ebc1a915-f643-4878-9d7a-67a9c6a26b20	2025-10-30	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	b60d1cc6-086c-4483-a101-c5f8d6000969	2025-10-29	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	Walgreens	be5ab61a-abd6-4dee-9607-2f1e2c47b2dc	2025-08-28	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Extended Release Caplets Maximum Strength	GUAIFENESIN, DEXTROMETHORPHAN HBR	Walgreens	11310cf8-ea34-47a2-b4d7-fe1131fef462	2025-08-28	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Maximum Strength	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rite Aid Corporation	8467474f-6278-47d9-8228-451d08ddf983	2025-08-20	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rite Aid Corporation	035693ed-d720-430b-98f5-fe4b5dec5db6	2025-08-20	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Maximum Strength	GUAIFENESIN, DEXTROMETHORPHAN HBR	Chain Drug Consortium, LLC	d6aae1a1-0ab9-4b26-9f62-b8761014bb35	2025-06-30	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	ATLANTIC BIOLOGICALS CORP.	308f50dd-e8d6-0264-e063-6394a90afa68	2025-06-27	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Amneal Pharmaceuticals LLC	5760a828-1c28-4272-a7b7-ac98466aa294	2024-10-25	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Amneal Pharmaceuticals LLC	cfdbcdb0-531a-4d95-ac5d-64d6d034b252	2024-10-25	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	H E B	20df2ffe-5281-4cd6-adb3-3a3d28788ef6	2024-08-02	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692

Additional Listing Data#

Finished product: Yes
Brand name base: Maximum Strength Guaifenesin DM

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	60 mg/1
GUAIFENESIN	1200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099074	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
2c9515f8-3120-4dbb-a7fc-d89fc5727148	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
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	Strength	SPL version
0536-1213-88	Maximum Strength Guaifenesin DM	14 in 1 CARTON	TABLET, EXTENDED RELEASE	14		9
0536-1213-88	Maximum Strength Guaifenesin DM	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1213-88	EA - Each	0536-1213	c8d59758-c58c-48ac-9ab2-ad82cf5db476	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1213	MAXIMUM STRENGTH GUAIFENESIN DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250327_2c9515f8-3120-4dbb-a7fc-d89fc5727148.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099074	guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet	PSN	2c9515f8-3120-4dbb-a7fc-d89fc5727148	9
1099074	12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet	SCD	2c9515f8-3120-4dbb-a7fc-d89fc5727148	9
1099074	dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	2c9515f8-3120-4dbb-a7fc-d89fc5727148	9
1099074	guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet	PSN	786607e9-ee2d-4510-8556-857032e4053f	3
1099074	12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet	SCD	786607e9-ee2d-4510-8556-857032e4053f	3
1099074	dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	786607e9-ee2d-4510-8556-857032e4053f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1213-88	00536121388	14 BLISTER PACK in 1 CARTON (0536-1213-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	14 blister pack	2018-11-05	2026-09-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Rugby Laboratories	2026-02-10	HUMAN OTC DRUG LABEL	9
Drug Facts	A-S Medication Solutions	2023-11-22	HUMAN OTC DRUG LABEL	3