TUSICOF

Product NDC: 52083-239
11-digit product format: 520830239
Labeler code: 52083
Product ID: 52083-239_e954ebb2-df25-40bf-b068-8ac861d6677b
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan, guaifenesin, and phenylephrine
Dosage form: SYRUP
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-08-17
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 20; 400; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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: TUSICOF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/5mL
GUAIFENESIN	400 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091331	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
e966b75c-4bb4-4216-8247-baada8f5d759	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52083-239-01	TUSICOF	30 mL in 1 BOTTLE	SYRUP	30	7
52083-239-04	TUSICOF	120 mL in 1 BOTTLE	SYRUP	120	7
52083-239-16	TUSICOF	474 mL in 1 BOTTLE	SYRUP	474	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-239-04	ML - Milliliter	52083-239	b715ea09-053c-42b6-ba32-08b9368055d4	1	2012-07-24
52083-239-16	ML - Milliliter	52083-239	38e2d9a5-bfde-4e35-90a8-1c6f4175a090	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-239	TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]	6	Current NDC, Legacy NDC, 3 package rows	20241011_e966b75c-4bb4-4216-8247-baada8f5d759.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 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zicam Extreme Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	ccada339-656c-a461-e053-2a95a90a3479	2025-12-31	Warnings	Exact identifier application number: M012
ED A-HIST DM	DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	e0e2b117-62bc-4132-9f7c-fe2a912052b1	2025-12-31	Warnings	Exact identifier application number: M012
Bio-Z-Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Advanced Generic Corporation	05e70eab-1467-4b09-991e-ef03f222e021	2025-12-31	Warnings	Exact identifier application number: M012
Altipres-B	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Alternative Pharmacal Corporation	fd00c41d-0580-4177-afaa-60bb12ca5a09	2025-12-31	Warnings	Exact identifier application number: M012
Ninjacof-D	CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	Centurion Labs, LLC	5188aa20-41f1-4998-81e1-f4de055874bc	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	4743e562-1217-50ab-e063-6394a90af88d	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	474459c1-bfd7-dec7-e063-6394a90ac18d	2025-12-31	Warnings	Exact identifier application number: M012
Geri Care Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICAL CORP	4744669c-7f33-e35f-e063-6394a90a79b7	2025-12-31	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	65545ca3-4e93-4b59-9e17-4742e086e8e7	2025-12-31	Warnings	Exact identifier application number: M012
GeriCare Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICALS, CORP	47451cd8-7aab-90e2-e063-6394a90ad1b7	2025-12-31	Warnings	Exact identifier application number: M012
Curewell Tussin	GUAIFENESIN	RMT HEALTH LLC	47455587-5074-e70d-e063-6294a90a78bb	2025-12-31	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Bestco Inc.	77e25027-3c96-21fa-e053-2991aa0a1f31	2025-12-31	Warnings	Exact identifier application number: M012
Puregen Labs Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	4745d4f9-bbdf-a4a6-e063-6294a90a15b2	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2a46ea9b-29e9-5197-e063-6394a90abc73	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77e50410-306d-b2fb-e053-2a91aa0af3c5	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	e086a6d2-f664-454e-9524-f656bfbf45df	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77f45efb-8ee0-1186-e053-2991aa0a9884	2025-12-31	Warnings	Exact identifier application number: M012
Conex Pediatric	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a46af43-ef36-e14e-e063-6394a90a8285	2025-12-31	Warnings	Exact identifier application number: M012
Conex	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a343656-ac6d-8b20-e063-6294a90ab319	2025-12-31	Warnings	Exact identifier application number: M012
Dologesic NF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	974fc0d5-7a99-46fb-af38-b91240f728fa	2025-12-31	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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1091331	dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution	PSN	e966b75c-4bb4-4216-8247-baada8f5d759	7
1091331	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution	SCD	e966b75c-4bb4-4216-8247-baada8f5d759	7
1091331	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution	SY	e966b75c-4bb4-4216-8247-baada8f5d759	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-239-01	52083023901	30 mL in 1 BOTTLE (52083-239-01)	30 ml	2010-08-17	0000-00-00	No	No	Current
52083-239-04	52083023904	120 mL in 1 BOTTLE (52083-239-04)	120 ml	2010-08-17	0000-00-00	No	No	Current
52083-239-16	52083023916	474 mL in 1 BOTTLE (52083-239-16)	474 ml	2012-10-08	0000-00-00	No	No	Current