Home NDC 51672-5293 Ovide
Product NDC 51672-5293
11-digit product format 516725293
Labeler code 51672
Product ID 51672-5293_f0a63cc5-d38b-45b2-8810-f9edcbbde2ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Malathion
Dosage form LOTION
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA091559
Marketing category ANDA
Marketing start 2014-01-31
Substance MALATHION
Active strength .0005 g/mL
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091559-001 MALATHION MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091559-001 MALATHION 0.5% LOTION / TOPICAL AT 2012-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091559-001 MALATHION 0.5% LOTION / TOPICAL RS 2012-05-23 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A091559-001 AT 1 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Ovide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MALATHION .0005 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U5N7SU872W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-5293-4 Ovide 1 in 1 CARTON LOTION 1 2 51672-5293-4 Ovide 59 mL in 1 BOTTLE LOTION 59 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-5293 OVIDE (MALATHION) LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Current NDC, Legacy NDC, 2 package rows 20180720_945f46fa-4b79-49fd-a890-477f251e2164.zip
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 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-5293-4 51672529304 1 BOTTLE in 1 CARTON (51672-5293-4) / 59 mL in 1 BOTTLE 1 bottle 2014-01-31 0000-00-00 No No Current