Home NDC 0682-0475 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 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 · 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 2026-12-31 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# 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