FDA.reportPublic FDA data

SERYNTH Clotrimazole

Product NDC
85248-101
11-digit product format
852480101
Labeler code
85248
Product ID
85248-101_5729a4d3-1503-946f-e063-6294a90a6384
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole1% Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-08
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
SERYNTH Clotrimazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a4b304a-1acc-9185-e063-6394a90a1176Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-101-01SERYNTH Clotrimazole30 g in 1 BOTTLECREAM301
85248-101-02SERYNTH Clotrimazole60 g in 1 BOTTLECREAM601

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 2 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-21WarningsExact identifier
application number: M005
GPPEE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.598d05bc-459d-71cf-e063-6394a90a19322026-08-21WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
application number: M005
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
application number: M005
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
application number: M005
BYT BANGYTONG FOLLICULITIS5% BENZOYL PEROXIDE FOLLICULITISShenzhen Jindali Technology Co., Ltd595363f9-6aee-93a5-e063-6394a90a0f0e2026-08-18WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEShield Line LLC9ddb13cd-34ed-2d63-e053-2a95a90ad9da2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESTOLNAFTATEYunqi Cosmetics (Shenzhen) Co., Ltd5939c492-6481-ddae-e063-6294a90a40bb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact identifier
application number: M005
APUREE Maximum Strength Athletes Foot AntifungalAPUREE MAXIMUM STRENGTH ATHLETES FOOT ANTIFUNGALGuangzhou Meixi Biotechnology Co., Ltd.593dc9a3-ae04-5642-e063-6294a90adb4b2026-08-17WarningsExact identifier
application number: M005
MENTOL CHINO FORTEMETHYL SALICYLATE, MENTHOL, CAMPHORLABORATORIOS H.G. C.A.12652c98-e2a8-21fc-e063-6394a90a94cb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER Sea Salt Green HerbsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59259ea7-f1bb-9688-e063-6394a90afb3c2026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Marshmallow VanillaALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5925e9a7-eb93-c0e3-e063-6294a90ad2652026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Lychee Vanilla MilkALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA592625c8-cbc5-f864-e063-6394a90aeb9d2026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN4a4b304a-1acc-9185-e063-6394a90a11761
309367clotrimazole 10 MG/ML Topical CreamSCD4a4b304a-1acc-9185-e063-6394a90a11761
309367clotrimazole 1 % Topical CreamSY4a4b304a-1acc-9185-e063-6394a90a11761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-101-018524801010130 g in 1 BOTTLE (85248-101-01) 30 g2026-02-08NoNoCurrent
85248-101-028524801010260 g in 1 BOTTLE (85248-101-02) 60 g2026-02-08NoNoCurrent