Home NDC 70677-1262 Clotrimazole
Product NDC 70677-1262
11-digit product format 706771262
Labeler code 70677
Product ID 70677-1262_3a767c0f-29db-c885-e063-6394a90aae7a
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route VAGINAL
Labeler STRATEGIC SOURCING SERVICES LLC
Application ANDA072641
Marketing category ANDA
Marketing start 2024-11-07
Substance CLOTRIMAZOLE
Active strength 1 g/100g
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 44 .
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 A072641-001 CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04
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 · 44 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 2026-10-15 13:18:30 2026-09 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Clotrimazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 1 g/100g
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 309368 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 70677-1262-1 Clotrimazole 45 g in 1 TUBE CREAM 45 3 70677-1262-1 Clotrimazole 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70677-1262 CLOTRIMAZOLE CREAM [STRATEGIC SOURCING SERVICES LLC] 2 Current NDC, 2 package rows 20241116_8c7cc657-28a1-4720-97ce-098207bfc470.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 · 4 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 70677-1262-1 70677126201 1 TUBE in 1 CARTON (70677-1262-1) / 45 g in 1 TUBE 1 tube 2024-11-07 No No Current