Home NDC 62583-001 BRONCOLIN
Product NDC 62583-001
11-digit product format 625830001
Labeler code 62583
Product ID 62583-001_eb01be3e-e6ad-7793-e053-2995a90a44f7
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form LOZENGE
Route ORAL
Labeler BRONCOLIN, S.A. de C.V.
Application M012
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-04-01
Marketing end 0000-00-00
Substance MENTHOL
Active strength 8 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
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 · 22 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 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 62583-001-16 367a005e9d99…383a685ebd0f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL ACTIVE INGREDIENT L7T10EIP3A BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 EUCALYPTUS PIPERITA LEAF INACTIVE INGREDIENT 4GG3SCZ7GT BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 HONEY INACTIVE INGREDIENT Y9H1V576FH BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 PROPOLIS WAX INACTIVE INGREDIENT 6Y8XYV2NOF BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 SAMBUCUS NIGRA FLOWER INACTIVE INGREDIENT 07V4DX094T BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1 VERBASCUM DENSIFLORUM FLOWER INACTIVE INGREDIENT N7FC535Q3R BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.] 1
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 68 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Menthol Cough Drops MENTHOL Walmart 124e6968-f59c-39d4-e063-6294a90a66d4 2025-12-23 Warnings Exact identifier application number: M012 Equate Severe Menthol Throat Drop MENTHOL Walmart 125f3f5a-52aa-e398-e063-6394a90a0012 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Chewable Gels MENTHOL Walmart 1ba4b2be-7242-0a23-e063-6294a90af29c 2025-12-23 Warnings Exact identifier application number: M012 Walgreens Severe Menthol Throat Drops MENTHOL Walgreens 21dd3c68-cbc6-4799-e063-6394a90a6972 2025-12-23 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Zee Medical 499d0748-538f-678c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 Guaiasorb DM DEXTROMETHORPHAN HBR, GUAIFENESIN NuCare Pharmaceuticals, Inc. 46a480c7-7092-b809-e063-6294a90a60cd 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 360a6304-206d-5475-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 36342d8c-34ab-6178-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Winco Foods 37244333-1307-5121-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco foods 37718c73-880e-4a5c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco Foods 40676ddc-577f-5cc9-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 Sugar Free Menthol Cough Drops MENTHOL Winco Foods 3788e8b6-ab9e-1513-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 SAFETUSSIN Non Drowsy Cough plus chest congestion DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES eeca6370-29ea-4540-8139-e8461d58a286 2025-12-23 Warnings Exact identifier application number: M012 Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Discount Drug Mart dd31f86b-f59e-459a-8e5f-176828706a4a 2025-12-23 Warnings Exact identifier application number: M012 Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Discount Drug Mart f8e7a08e-7422-4a1b-bfec-93e0b50d10cd 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ae97-7951-4058-e053-2995a90a7b2e 2025-12-23 Warnings Exact identifier application number: M012 Childrens Chest Congestion Relief Grape GUAIFENESIN Discount Drug Mart 3e5d245f-515c-4106-a855-fb97681b646a 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ed16-86bb-3faf-e053-2995a90acfbc 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 2025-12-23 Warnings Exact identifier application number: M012 Safetussin High Blood Pressure and diabetes Cough, Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES 279e309c-040d-4001-808d-b7d986a9a1d8 2025-12-23 Warnings Exact identifier application number: M012
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62583-001-16 62583000116 16 LOZENGE in 1 BOX (62583-001-16) 16 lozenge 2014-04-01 0000-00-00 No No Current