NeoTuss S/F

Product NDC: 12539-555
11-digit product format: 125390555
Labeler code: 12539
Product ID: 12539-555_463c3e8f-7445-efdd-e063-6394a90a660b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Dextromethorphan HBr
Dosage form: LIQUID
Route: ORAL
Labeler: DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-02-28
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 200; 30 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: NeoTuss S/F
Brand name suffix: Grape-Menthol Flavor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	200 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	30 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
1147924	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
2f3df82c-1926-5238-e063-6294a90a7bbf	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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12539-555-01	NeoTuss S/FGrape-Menthol Flavor	30 mL in 1 BOTTLE	LIQUID	30		2
12539-555-16	NeoTuss S/FGrape-Menthol Flavor	474 mL in 1 BOTTLE	LIQUID	474		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12539-555-16	ML - Milliliter	12539-555	50d9fbb2-fd78-4385-a5fc-7ee9d9b9a058	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12539-555	NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS]	1	Current NDC, 1 package rows	20250322_2fac3425-32f0-38d6-e063-6394a90a6e7a.zip
12539-555	NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS]	1	Current NDC, 1 package rows	20250303_2f3df82c-1926-5238-e063-6294a90a7bbf.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 78 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
24-7 Life BY 7-ELEVEN Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION	Lil' Drug Store products, Inc.	277363f4-1c00-ddb7-e063-6294a90a4677	2025-12-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION	Lil' Drug Store Products, Inc.	2771d699-3f70-4318-e063-6394a90a89cc	2025-12-09	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b	2025-12-09	Warnings	Exact identifier application number: M012
Circle K Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc	9a32bc6d-0499-48fa-a6ad-702c8a28bf5f	2025-12-09	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	5015a380-a229-4eff-8e31-528065c6ed64	2025-12-09	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	caf59320-5b48-4533-bda9-7b03a2fde0b5	2025-12-09	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	30d41dc3-e2ef-4cad-b63c-d634bc749aa1	2025-12-09	Warnings	Exact identifier application number: M012
Walgreens Childrens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	327a7226-84b9-26d7-e063-6394a90a99b9	2025-12-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Meijer Distribution Inc	8ed5b802-a26e-45b4-a696-bc64dbac4733	2025-12-09	Warnings	Exact identifier application number: M012
dg health cold plus flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ff4a2f0a-d638-4ed2-8e05-2a52afbc4909	2025-12-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	24894484-b834-4b2f-b365-c95b5e30d8bf	2025-12-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Family Dollar (FAMILY WELLNESS)	2c431220-c61b-4ad5-9ad2-58ccaee2d1c3	2025-12-09	Warnings	Exact identifier application number: M012
Sinus PE Congestion Daytime Nighttime	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	9da77306-5098-4c79-845c-97ead849c84a	2025-12-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fdd0dadc-5313-4f6e-aef5-ca853efe5c4d	2025-12-08	Warnings	Exact identifier application number: M012
Mucolyte	GUAIFENESIN	Rising Pharma Holdings, Inc.	e4091aaf-44e3-4701-9986-aff248a2f1b8	2025-12-08	Warnings	Exact identifier application number: M012
Mucolyte DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rising Pharma Holdings, Inc.	c913d27d-bc00-4ace-9a5f-c55522e1cd1d	2025-12-08	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	American Sales	47f504d5-3ec5-5227-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
Sugar Free Menthol Cough Drops	MENTHOL	American Sales	4893ac0a-7769-5657-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	American Sales	45e891ea-2f2a-31b7-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenge	BENZOCAINE	American Sales	49248a40-1ca3-6dd1-e054-00144ff88e88	2025-12-07	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
1147924	dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral Solution	PSN	2f3df82c-1926-5238-e063-6294a90a7bbf	2
1147924	dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral Solution	PSN	2fac3425-32f0-38d6-e063-6394a90a6e7a	2
1147924	dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral Solution	SCD	2f3df82c-1926-5238-e063-6294a90a7bbf	2
1147924	dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral Solution	SCD	2fac3425-32f0-38d6-e063-6394a90a6e7a	2
1147924	dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral Solution	SY	2f3df82c-1926-5238-e063-6294a90a7bbf	2
1147924	dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral Solution	SY	2fac3425-32f0-38d6-e063-6394a90a6e7a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
12539-555-01	12539055501	30 mL in 1 BOTTLE (12539-555-01)	30 ml	2025-02-28	No	No	Current
12539-555-16	12539055516	474 mL in 1 BOTTLE (12539-555-16)	474 ml	2025-03-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NeoTuss S/F Grape-Menthol Flavor	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals \| DEXTRUM LABORATORIES INC	2025-12-18	HUMAN OTC DRUG LABEL	2
NeoTuss S/F Grape-Menthol Flavor	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals \| DEXTRUM LABORATORIES INC	2025-12-18	HUMAN OTC DRUG LABEL	2