Home NDC 43913-402 G-BUCAL-C
Product NDC 43913-402
11-digit product format 439130402
Labeler code 43913
Product ID 43913-402_8cf80886-2241-4e7c-af0e-50da491bf38e
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM and ZINC CHLORIDE
Dosage form SPRAY
Route OROPHARYNGEAL
Labeler MCLAREN MEDICAL INC
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-01-01
Marketing end 0000-00-00
Substance MENTHOL, UNSPECIFIED FORM; ZINC CHLORIDE
Active strength 45 mg/30mL; mg/30mL
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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 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 43913-402-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 43913-402-30 G-BUCAL-C 30 mL in 1 BOTTLE, SPRAY SPRAY 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL, UNSPECIFIED FORM ACTIVE INGREDIENT L7T10EIP3A G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 ZINC CHLORIDE ACTIVE INGREDIENT 86Q357L16B G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 MENTHOL, UNSPECIFIED FORM ACTIVE MOIETY L7T10EIP3A G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 BENZOCAINE INACTIVE INGREDIENT U3RSY48JW5 G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 CETYLPYRIDINIUM CHLORIDE INACTIVE INGREDIENT D9OM4SK49P G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43913-402 G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC] 1 Legacy NDC, 1 package rows 20150922_31690548-0a55-4d72-8733-591ba3a9be92.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 43913-402-30 43913040230 30 mL in 1 BOTTLE, SPRAY 30 ml Historical