Home NDC 55621-003 TheraPlus
Product NDC 55621-003
11-digit product format 556210003
Labeler code 55621
Product ID 55621-003_08ad180e-e87c-ba6f-e063-6394a90a2bc7
Type HUMAN OTC DRUG
Nonproprietary name CLOTRIMAZOLE
Dosage form CREAM
Route TOPICAL
Labeler Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-03-01
Substance CLOTRIMAZOLE
Active strength 1 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 TheraPlus
Brand name suffix Plus
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 309367 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 55621-003-01 TheraPlusPlus 35 g in 1 TUBE CREAM 35 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 GLYCERYL STEARATE SE INACTIVE INGREDIENT FCZ5MH785I THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 LAURETH-23 INACTIVE INGREDIENT N72LMW566G THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55621-003 THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 5 Current NDC, Legacy NDC, 1 package rows 20231101_de75179d-1889-4823-9f39-4bebdf185d76.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 48 of 49 · 969 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Black Bottle Tea Tree Antifungal Foot and Body Wash TOLNAFTATE Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) 2c966d97-30f5-4942-b64d-742884ce6a2f 2023-11-10 Warnings Exact identifier application number: M005 Smooth Gator Fungus Eliminator CLOTRIMAZOLE Smooth Gator, LLC 262b04f5-1b5d-4c67-a557-01f8b1711302 2023-11-10 Warnings Exact identifier application number: M005 TOLNAFTATE ANTIFUNGAL TOLNAFTATE Geri-Care Pharmaceuticals, Corp f9e60430-eec1-4bc2-9522-eb5aa527d90a 2023-11-08 Warnings Exact identifier application number: M005 Terrasil Jock Itch Treatment Maximum Strength CLOTRIMAZOLE Aidance Skincare & Topical Solutions, LLC c62fbf23-5d19-44ab-9c1a-e9b803192ed0 2023-11-08 Warnings Exact identifier application number: M005 terrasil The Fungal Solution Kit CLOTRIMAZOLE Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 9a5eb581-62a2-41fe-a174-e852fc47e235 2023-11-08 Warnings Exact identifier application number: M005 EmoniNail Antifungal UNDECYLENIC ACID GG Healthworks Inc. 84ace47a-d3ae-4735-87b6-dbbf1c40cf54 2023-11-06 Warnings Exact identifier application number: M005 CIDACIN Antifungal Treatment TOLNAFTATE Pedicis Research LLC bd53a9e3-65c8-4834-8e23-a2a928b83a66 2023-11-05 Warnings Exact identifier application number: M005 MacerRx Web MICONAZOLE NITRATE Clinical Therapeutic Solutions c9327f41-10f1-41f3-855b-838c701d6767 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 7e8897ff-67d1-4336-866e-cb76a36edddc 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 308a91d1-3511-4e2d-a62f-a31d77d70e06 2023-11-05 Warnings Exact identifier application number: M005 Human Science Antifungal Foot Care UNDECYLENIC ACID HUMAN SCIENCE, LLC 26b2519b-7d7b-4b33-b5d6-a41fe6f73538 2023-11-05 Warnings Exact identifier application number: M005 HomeHealth Antifungal TOLNAFTATE Home Health 895cd24c-3f78-4e2e-bf98-8bb6605798da 2023-11-05 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Proficient Rx LP 800a9dab-d287-427e-af6d-26996e0def41 2023-11-01 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE-IODINE Dr Radows 58e1757c-45ce-455e-bd64-a9e99cd3680f 2023-10-30 Warnings Exact identifier application number: M005 JOCK-EZE CLOTRIMAZOLE Bentlin Products LLC d3ff5bfb-2e0f-4daa-84b3-4a3016ca9280 2023-10-30 Warnings Exact identifier application number: M005 TheraPlus Plus CLOTRIMAZOLE Zhejiang Jingwei Pharmaceutical Co., Ltd. de75179d-1889-4823-9f39-4bebdf185d76 2023-10-27 Warnings Exact identifier application number: M005 ndc (product): 55621-003 Evercare Antifungal Treatment Super Absorbent Powder MICONAZOLE NITRATE PANEFFORT, LLC f91910f3-b461-43a4-9120-fda69483fffa 2023-10-26 Warnings Exact identifier application number: M005 Thera plus Antifungal Clotrimazole CLOTRIMAZOLE FOURSTAR GROUP USA, INC. 1265be99-8922-4b76-bd63-19bfb42c3896 2023-10-26 Warnings Exact identifier application number: M005 Thera plus Antifungal Tolnaftate TOLNAFTATE FOURSTAR GROUP USA, INC. c628dda8-7a6d-5f3a-e053-2995a90a35f8 2023-10-26 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE IODINE Jianerkang Medical Co., Ltd e1789944-3a41-4c86-b173-3a6993ae2141 2023-10-23 Warnings Exact identifier application number: M005
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55621-003-01 55621000301 35 g in 1 TUBE (55621-003-01) 35 g 2013-03-01 0000-00-00 No No Current