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United States · US · US:0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5
Crotan
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMarnel Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110682005110237 g in 1 BOTTLE, PLASTIC (0682-0051-10)
- ndc11068200512060 g in 1 BOTTLE, PLASTIC (0682-0051-20)
- ndc110682005130454 g in 1 BOTTLE, PLASTIC (0682-0051-30)
Annotations
UNII (FDA Substance ID)
D6S4O4XD0H
CROTAMITON
RxCUI 21766
Orange Book
A087204
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "D6S4O4XD0H",
"rxcui": "21766",
"inchikey": null,
"display_name": "CROTAMITON",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"6f7478fa-ed2b-4943-9d40-1fd0161a0854": {
"match": "brand_token",
"title": "CROTAN (CROTAMITON) LOTION [MARNEL PHARMACEUTICALS, INC.]",
"spl_version": "11",
"published_date": "2024-04-22"
}
},
"productid": "0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5",
"productndc": "0682-0051",
"dosage_form": "LOTION",
"orange_book": {
"appl_no": "087204",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "10%",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CROTAMITON",
"proprietary_name": "Crotan",
"active_ingred_unit": "mg/g",
"application_number": "ANDA087204",
"marketing_category": "ANDA",
"nonproprietary_name": "Crotamiton",
"start_marketing_date": "20220115",
"active_numerator_strength": "100"
}Access this data programmatically
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