Home NDC 53145-321 Bisolvine
Product NDC 53145-321
11-digit product format 531450321
Labeler code 53145
Product ID 53145-321_8703a2fc-23ae-4432-8a03-da49a1b166ca
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Dextromethorphan
Dosage form LIQUID
Route ORAL
Labeler MENPER DISTRIBUTORS INC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-02-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 100 mg/5mL; mg/5mL
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 53145-321 E Excluded after deficient or non-compliant submission was not corrected 2026-10-05 excluded package package 53145-321 53145-321-04 E Excluded after deficient or non-compliant submission was not corrected 2026-10-05
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 · 16 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 E Excluded after deficient or non-compliant submission was not corrected d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53145-321-04 E Excluded after deficient or non-compliant submission was not corrected d630ba8d3edf…732f749b63fb…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 53145-321-04 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 53145-321-04 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 53145-321-04 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 53145-321-04 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 53145-321-04 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 53145-321-04 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 53145-321-04 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 53145-321-04 BisolvineAdult 120 mL in 1 BOTTLE, PLASTIC LIQUID 120 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BISOLVINE ADULT (GUAIFENESIN, DEXTROMETHORPHAN) LIQUID [MENPER DISTRIBUTORS INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53145-321-04 53145032104 120 mL in 1 BOTTLE, PLASTIC 120 ml Historical