Home NDC 16571-686 CLOTRIMAZOLE
Product NDC 16571-686
11-digit product format 165710686
Labeler code 16571
Product ID 16571-686_de2c09da-6280-4873-859a-80e779643612
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOTRIMAZOLE
Dosage form LOZENGE
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA215641
Marketing category ANDA
Marketing start 2024-05-01
Substance CLOTRIMAZOLE
Active strength 10 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 A215641-001 CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215641-001 AB
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 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215641-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2024-02-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CLOTRIMAZOLE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309371 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 16571-686-07 CLOTRIMAZOLE 70 in 1 BOTTLE LOZENGE 70 2 16571-686-14 CLOTRIMAZOLE 140 in 1 BOTTLE LOZENGE 140 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-686 CLOTRIMAZOLE LOZENGE [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 2 package rows 20240501_980736aa-751a-4642-ab85-a309435fd02f.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 · 1 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 16571-686-07 16571068607 70 LOZENGE in 1 BOTTLE (16571-686-07) 70 lozenge 2024-05-01 No No Current 16571-686-14 16571068614 140 LOZENGE in 1 BOTTLE (16571-686-14) 140 lozenge 2024-05-01 No No Current