Home NDC 58805-007 Cough and Congestion DM
Product NDC 58805-007
11-digit product format 588050007
Labeler code 58805
Product ID 58805-007_4e88b254-c0b1-48bf-9ca5-b13a22118204
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan and Guaifenesin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Agile Pharmachem
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-11-08
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10 mg/1; mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58805-007-75 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58805-007-75 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58805-007-75 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58805-007-75 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58805-007-75 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58805-007-75 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58805-007-75 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58805-007-75 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58805-007-75 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58805-007-75 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58805-007-75 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58805-007-75 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58805-007-75 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58805-007-75 834df4deac94…adcc014656a3…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 58805-007-75 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 58805-007-75 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 58805-007-75 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 58805-007-75 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 58805-007-75 8dfbde2a14a4…c9ff85d89658…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 58805-007-75 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 58805-007-75 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 58805-007-75 Cough and Congestion DM 7500 in 1 CAPSULE CAPSULE, LIQUID FILLED 7500 1 58805-007-75 Cough and Congestion DM 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58805-007 COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM] 1 Legacy NDC, 2 package rows 20151113_1a7fa7fd-435f-4a94-9d7e-7b7e83e9f97e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 58805-007-75 58805000775 7500 in 1 CAPSULE Historical