Home NDC 59561-202 BRONCO SILEN-DM
Product NDC 59561-202
11-digit product format 595610202
Labeler code 59561
Product ID 59561-202_e90ddf21-87ce-462b-8344-5a578b17d52c
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form SOLUTION
Route ORAL
Labeler Caribe Natural, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-11-05
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20 mg/10mL; mg/10mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59561-202-04 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59561-202-04 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59561-202-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59561-202-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59561-202-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59561-202-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59561-202-04 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59561-202-04 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59561-202-04 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59561-202-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59561-202-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 59561-202-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 59561-202-04 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 59561-202-04 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 59561-202-04 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 59561-202-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 59561-202-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 59561-202-04 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 59561-202-04 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 59561-202-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 59561-202-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 59561-202-04 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 59561-202-04 BRONCO SILEN-DM 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%) INACTIVE INGREDIENT 2Q40985DRM BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59561-202 BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] 1 Legacy NDC, 1 package rows 20151112_baf96bf1-7e70-4f08-9514-6f0d4cde6d88.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 59561-202-04 59561020204 118 mL in 1 BOTTLE, PLASTIC 118 ml Historical