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: 2027-12-31
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: 2027-12-31

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 144 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier application number: M012
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier application number: M012
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier application number: M012
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier application number: M012
dg health nasal original	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	fb209752-705a-4bb0-9298-8b70357f3911	2024-11-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	3c301993-642a-487c-96a2-ebc4ef90dc88	2024-11-02	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier application number: M012
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	28ef87e8-29e5-444d-b1f7-5c38a7f758d3	2024-11-01	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	0e3c36c9-d45b-41b9-891d-a42d854295f9	2024-11-01	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	7dc3941a-e5f8-4caa-bae5-6a0d075295cb	2024-11-01	Warnings	Exact identifier application number: M012
DoloMax Cold Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	BENARD INDUSTRIES INC	520aee75-8b9a-4dcc-8970-75e122640e91	2024-10-31	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe	2024-10-31	Warnings	Exact identifier application number: M012
CareOne Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	American Sales Company	819d5c82-0240-4013-9904-c335bd65d03e	2024-10-30	Warnings	Exact identifier application number: M012
Signature Care Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway	9a0ad5d5-8fd9-468d-be2c-87c14d08b934	2024-10-30	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2	2024-10-30	Warnings	Exact identifier application number: M012
dg health cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp, LLC	81f3ac36-9bae-4f42-92a0-8a2e4bbd0984	2024-10-30	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Rite Aid Corporation	9a71e8eb-4195-4694-bf3e-44f691ff2cef	2024-10-30	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	H E B	fe4a95d2-6fb3-43fe-baec-6f22d1965323	2024-10-30	Warnings	Exact identifier application number: M012
NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger Company	2c9ef0d7-3d5b-494a-8f06-9dd42110d78a	2024-10-30	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