MAR-COF CG

Product NDC: 0682-0475
11-digit product format: 006820475
Labeler code: 0682
Product ID: 0682-0475_13b802bb-b30a-864a-e063-6394a90a4dfd
Type: HUMAN OTC DRUG
Nonproprietary name: CODEINE PHOSPHATE and GUAIFENESIN
Dosage form: SYRUP
Route: ORAL
Labeler: Marnel Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-12-01
Substance: CODEINE PHOSPHATE; GUAIFENESIN
Active strength: 7.5; 225 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 10 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
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0682-0475-16	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0682-0475-16	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0682-0475-16	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0682-0475-16	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0682-0475-16	`8dfbde2a14a4…`	`c9ff85d89658…`

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: MAR-COF CG
Brand name suffix: Expectorant
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CODEINE PHOSPHATE	7.5 mg/5mL
GUAIFENESIN	225 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GSL05Y1MN6	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995441	Internal RxNorm lookup
995443	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
60a41229-b125-43d8-b2b4-0bf40feed764	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
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
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-03-15	MAR-COF ® CG Expectorant
2024-01-30	MAR-COF ® CG Expectorant
2022-10-17	MAR-COF ® CG Expectorant
2021-07-23	MAR-COF ® CG Expectorant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0682-0475-16	MAR-COF CGExpectorant	473 mL in 1 BOTTLE	SYRUP	473		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0682-0475-16	ML - Milliliter	0682-0475	96e067ee-d836-4dbd-aa6a-1ca12507d95b	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0682-0475	MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTICALS, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240316_60a41229-b125-43d8-b2b4-0bf40feed764.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 141 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.	Kenvue Brands LLC	f81d924e-10e9-0e9d-e053-6294a90a2ddf	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8b516736-86ac-47cb-a0ec-038d4c3a0020	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu plus Cough Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e85e5eb9-3ecf-4784-999e-111e38e306f5	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier application number: M012
Primatene	EPHEDRINE HYDROCHLORIDE	Foundation Consumer Brands	2170f081-c03f-47e8-bc63-4052c5e653fa	2024-11-07	Warnings	Exact identifier application number: M012
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier application number: M012
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	1a8e2e03-e11b-4da1-945b-e2caadea7243	2024-11-07	Warnings	Exact identifier application number: M012
SUDOGEST NASAL DECONGESTANT	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	2024-11-07	Warnings	Exact identifier application number: M012
up and up childrens allergy melts	DIPHENHYDRAMINE HCL	Target Corporation	f98d1d54-8e11-4bb1-825a-ab5447d37847	2024-11-07	Warnings	Exact identifier application number: M012
good sense severe day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	44130a1b-63cc-42ac-9590-fdf21a12d164	2024-11-07	Warnings	Exact identifier application number: M012
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	a5ff1134-8985-4585-8e61-a5fd5f60afeb	2024-11-07	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	50528d29-ce8c-4efb-a86c-17246b017db0	2024-11-07	Warnings	Exact identifier application number: M012
cooling severe daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	d4a21760-b2bd-4e26-bff0-6fc1b05d26b3	2024-11-07	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	60870311-3234-44ba-95dd-09cf4ea3d508	2024-11-07	Warnings	Exact identifier application number: M012
adult dm max cough and chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution Inc	3a6855c1-da6d-4fa9-81fe-d2e61355989f	2024-11-06	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	e51dfb62-40d0-4bec-9574-90057cb35bcc	2024-11-06	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995441	codeine phosphate 7.5 MG / guaiFENesin 225 MG in 5 mL Oral Solution	PSN	60a41229-b125-43d8-b2b4-0bf40feed764	5
995443	MAR-COF CG 7.5 MG / 225 MG in 5 mL Oral Solution	PSN	60a41229-b125-43d8-b2b4-0bf40feed764	5
995443	codeine phosphate 1.5 MG/ML / guaifenesin 45 MG/ML Oral Solution [Mar-cof CG]	SBD	60a41229-b125-43d8-b2b4-0bf40feed764	5
995441	codeine phosphate 1.5 MG/ML / guaifenesin 45 MG/ML Oral Solution	SCD	60a41229-b125-43d8-b2b4-0bf40feed764	5
995441	codeine phosphate 7.5 MG / guaifenesin 225 MG per 5 ML Oral Solution	SY	60a41229-b125-43d8-b2b4-0bf40feed764	5
995443	Mar-cof CG (codeine phosphate 7.5MG / guaifenesin 225 MG) per 5 ML Oral Solution	SY	60a41229-b125-43d8-b2b4-0bf40feed764	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0682-0475-16	00682047516	473 mL in 1 BOTTLE (0682-0475-16)	473 ml	2008-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MAR-COF ® CG Expectorant	Marnel Pharmaceuticals, LLC \| Marnel Pharmaceuticals LLC	2024-03-15	HUMAN OTC DRUG LABEL	5