FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0682-0475-161332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0682-0475-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0682-0475-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0682-0475-16bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0682-0475-168dfbde2a14a4…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
IngredientStrength
CODEINE PHOSPHATE7.5 mg/5mL
GUAIFENESIN225 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GSL05Y1MN6Internal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995441Internal RxNorm lookup
995443Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60a41229-b125-43d8-b2b4-0bf40feed764Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0682-0475-16MAR-COF CGExpectorant473 mL in 1 BOTTLESYRUP4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0682-0475-16ML - Milliliter0682-047596e067ee-d836-4dbd-aa6a-1ca12507d95b12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0682-0475MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20240316_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 161 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETARGET CORPORATION135d2212-2122-b7a1-e063-6294a90aa5f52024-06-07WarningsExact identifier
application number: M012
up and up daytime honey cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETarget Corporation29da4b94-8f8e-48e8-909f-8476e3b39d782024-06-06WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCITARGET Corporatione3da3003-88e3-4431-8b65-e61e177289012024-06-04WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATEFoundation Consumer Healthcare15c3570c-bd00-8e43-e063-6294a90a86832024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare176be362-5237-edd8-e063-6294a90a4aef2024-06-01WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare179115ad-d610-99b2-e063-6294a90ae7112024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare179259a9-231e-df03-e063-6294a90a145e2024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CoughBROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Healthcare1820e7c7-bc11-9061-e063-6394a90ae5812024-06-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLC682c5a4b-5ded-4276-903f-1ef1141ae5182024-06-01WarningsExact identifier
application number: M012
Maximum Strength Nasal DecongestantOXYMETAZOLINE SPRAYCVS Healthdf1f8bda-7bf3-4755-9169-f2a81d824cbe2024-05-31WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healtha78d29ed-019b-4014-ae6f-c60c75d19c892024-05-31WarningsExact identifier
application number: M012
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc6594c117-6ffc-4bda-8bbf-e91c810f2c3f2024-05-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI1aba9b7c-8328-4a9f-8ce2-39648b2d8ae42024-05-23WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIfdf63308-fe7b-4613-a012-ed5e4c9f8ffe2024-05-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIe61ab02d-f932-403f-a4f7-0ca3546072232024-05-23WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIe4f9a846-ab72-4508-b0c5-f7911af2f3d72024-05-23WarningsExact identifier
application number: M012
Adult Cough ReliefDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2024-05-20WarningsExact identifier
application number: M012
Chlorpheniramine Maleate 4 mgCHLORPHENIRAMINE MALEATEBryant Ranch Prepack54681242-c861-4415-b5c0-d3ab55b62be12024-05-17WarningsExact identifier
application number: M012
Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c830b18b-4427-4530-9bc7-85c2735080d22024-05-17WarningsExact identifier
application number: M012
Childrens Cold and Cough NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLSafeway, Inc.cbbec807-f882-4c6a-b1cd-c7fd5ce70cad2024-05-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995441codeine phosphate 7.5 MG / guaiFENesin 225 MG in 5 mL Oral SolutionPSN60a41229-b125-43d8-b2b4-0bf40feed7645
995443MAR-COF CG 7.5 MG / 225 MG in 5 mL Oral SolutionPSN60a41229-b125-43d8-b2b4-0bf40feed7645
995443codeine phosphate 1.5 MG/ML / guaifenesin 45 MG/ML Oral Solution [Mar-cof CG]SBD60a41229-b125-43d8-b2b4-0bf40feed7645
995441codeine phosphate 1.5 MG/ML / guaifenesin 45 MG/ML Oral SolutionSCD60a41229-b125-43d8-b2b4-0bf40feed7645
995441codeine phosphate 7.5 MG / guaifenesin 225 MG per 5 ML Oral SolutionSY60a41229-b125-43d8-b2b4-0bf40feed7645
995443Mar-cof CG (codeine phosphate 7.5MG / guaifenesin 225 MG) per 5 ML Oral SolutionSY60a41229-b125-43d8-b2b4-0bf40feed7645

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0682-0475-1600682047516473 mL in 1 BOTTLE (0682-0475-16) 473 ml2008-12-010000-00-00NoNoCurrent