Home NDC 76206-001-01 COUGH BE GONE
Product NDC 76206-001
Requested package NDC 76206-001-01
11-digit product format 762060001
Labeler code 76206
Product ID 76206-001_a6cf8d75-ab8f-4044-e053-2a95a90a02e1
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler RFX Pharmaceutical Co., Ltd.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-01-30
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20 mg/10mL; mg/10mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 19 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 76206-001-01 COUGH BE GONE 6 in 1 BOX LIQUID 6 4 76206-001-10 COUGH BE GONE 10 mL in 1 BOTTLE, GLASS LIQUID 10 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 ALMOND OIL INACTIVE INGREDIENT 66YXD4DKO9 COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 ERIOBOTRYA JAPONICA LEAF INACTIVE INGREDIENT Z02066SV11 COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 GINGER INACTIVE INGREDIENT C5529G5JPQ COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 HONEY INACTIVE INGREDIENT Y9H1V576FH COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 LICORICE INACTIVE INGREDIENT 61ZBX54883 COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76206-001 COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.] 4 Legacy NDC, 2 package rows 20200530_89a5588f-a6a6-40dd-b96f-79bd3ea9e31f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 76206-001-01 76206000101 6 BOTTLE, GLASS in 1 BOX (76206-001-01) > 10 mL in 1 BOTTLE, GLASS (76206-001-10) 2014-01-30 0000-00-00 No No Current