Home NDC 15370-220 CLOTIC (clotrimazole) otic solution
Product NDC 15370-220
11-digit product format 153700220
Labeler code 15370
Product ID 15370-220_5a7a78a3-12b4-43f9-9212-fc7db56ca3f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clotrimazole
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler Carwin Pharmaceutical Associates, LLC
Application NDA217628
Marketing category NDA
Marketing start 2026-02-19
Substance CLOTRIMAZOLE
Active strength 1.7 mg/.17mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N217628-001 CLOTIC CLOTRIMAZOLE 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 2026-09-14 22:38:34 2026-08 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 a50c72e98297…
Observed Orange Book exclusivity history# 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 CLOTIC (clotrimazole) otic solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 1.7 mg/.17mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2725165 Internal RxNorm lookup 2725626 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 15370-220-28 CLOTIC (clotrimazole) otic solution 2 in 1 CARTON LIQUID 2 1 15370-220-28 CLOTIC (clotrimazole) otic solution 14 in 1 POUCH LIQUID 14 1 15370-220-99 CLOTIC (clotrimazole) otic solution 1 in 1 CARTON LIQUID 1 1 15370-220-99 CLOTIC (clotrimazole) otic solution 2 in 1 POUCH LIQUID 2 1
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 15370-220-28 15370022028 2 POUCH in 1 CARTON (15370-220-28) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE 2 pouch 2026-02-19 No No Current 15370-220-99 15370022099 1 POUCH in 1 CARTON (15370-220-99) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE 1 pouch 2026-02-19 Yes No Current