Biocof

Product NDC: 45737-249
11-digit product format: 457370249
Labeler code: 45737
Product ID: 45737-249_472ea774-30a5-89c8-e063-6394a90a0036
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HCL
Dosage form: LIQUID
Route: ORAL
Labeler: Advanced Generic Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-07-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	45737-249-16	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	45737-249-16	`9bebd1f3094a…`	`5416666fcb17…`

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: Biocof
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
6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45737-249-16	2020-12-23	C162847	48780-1	9d75b9d0-1123-f424-e053-dadaa90a57ce	AGC-Biocof 249
45737-249-16	2020-01-31	C162847	48780-1	9d75b9d0-1123-f424-e053-dadaa90a57ce	AGC-Biocof 249

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45737-249-16	Biocof	473 mL in 1 BOTTLE	LIQUID	473		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45737-249-16	ML - Milliliter	45737-249	14e73989-40d3-47ac-9905-eeaa1120c08e	1	2025-07-08

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45737-249	BIOCOF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]	5	Current NDC, Legacy NDC, 1 package rows	20241228_6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6.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 77 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f6401b58-8cf8-4067-e053-2995a90a68fc	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1ba37b8-4558-0808-e053-2995a90a9f5e	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b84f37bc-be37-4f2b-83ee-d7d134184490	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b7c7fc-1068-f486-e053-2a95a90a8e8c	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b9e0da-2c54-8b31-e053-2995a90a690b	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	f6b3ca40-7638-477f-b800-4c28c40ff0a8	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	0a6e3251-02e0-42c1-bdf3-51c77f88c17f	2025-12-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	516ab016-31f9-4829-8b94-2f968933093c	2025-12-11	Warnings	Exact identifier application number: M012
Sinus PE Congestion	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	5b9151b7-3e40-4f37-b3e0-4c0fa0115b71	2025-12-10	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Discount Drug Mart	2344c048-0550-4c31-b54e-a198910c490e	2025-12-10	Warnings	Exact identifier application number: M012
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY, INC	cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe, Lil Drug Store	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	f395c196-62d7-47ff-b38d-af37adf5980b	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe, Lil Drug Store	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	88b68447-b016-4d5b-a5e3-c4ebccb14f8c	2025-12-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	d956f1b8-91f8-424b-bb6c-704c445b6f4c	2025-12-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	e5c1bd96-d27d-49c1-b3b8-eee53a145ef5	2025-12-10	Warnings	Exact identifier application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe67bf-2c66-61e6-e063-6394a90a7f8f	2025-12-10	Warnings	Exact identifier application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe0f43-b92a-f947-e063-6394a90ab72c	2025-12-10	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7285fe0-5a5b-42c4-be47-9a07a2ba75e8	2025-12-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	f9b8dbe1-7ff9-4320-850c-6e86e98d4393	2025-12-09	Warnings	Exact identifier application number: M012
Severe Nasal	OXYMETAZOLINE HYDROCHLORIDE 0.05%	ALAINA HEALTHCARE PRIVATE LIMITED	27747a10-8d1d-41c2-80b9-45452f3b9abc	2025-12-09	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	6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6	6
1091331	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution	SCD	6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6	6
1091331	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution	SY	6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45737-249-16	45737024916	473 mL in 1 BOTTLE (45737-249-16)	473 ml	2012-07-01	0000-00-00	No	No	Current