Home NDC 82392-200-04 RID One and Done
Product NDC 82392-200
Requested package NDC 82392-200-04
11-digit product format 823920200
Labeler code 82392
Product ID 82392-200_2fc2e0fd-e442-d3f5-e063-6394a90a8473
Type HUMAN OTC DRUG
Nonproprietary name Ivermectin
Dosage form LOTION
Route TOPICAL
Labeler Oystershell Consumer Health, Inc.
Application ANDA210720
Marketing category ANDA
Marketing start 2024-08-02
Substance IVERMECTIN
Active strength 5 mg/g
Pharmacologic classes Antiparasitic [EPC], Pediculicide [EPC]
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 1 .
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 A210720-001 IVERMECTIN IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06
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.
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 2026-02-19 14:30 UTC 2026-02 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL AB 2020-05-06 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2020-11-12 02:37 UTC 2020-11 A210720-001 AB 1 c0c555d07b60…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A210720-001 PC 2021-05-29 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base RID One and Done
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVERMECTIN 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8883YP2R6D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1246673 Internal RxNorm 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 82392-200-04 RID One and Done 117 g in 1 TUBE LOTION 117 3 82392-200-04 RID One and Done 1 in 1 CARTON LOTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82392-200 RID ONE AND DONE (IVERMECTIN) LOTION [OYSTERSHELL CONSUMER HEALTH, INC.] 3 Current NDC, 2 package rows 20250309_731a15f8-3578-4a95-b04c-aa6cf44a4665.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 · 9 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82392-200-04 82392020004 1 TUBE in 1 CARTON (82392-200-04) / 117 g in 1 TUBE 1 tube 2024-08-02 No No Current