🇺🇸
United States · US · US:21130-183_22865692-fb31-425b-ac78-2d3cd7998c04
signature care anti diarrheal anti gas
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSafeway
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11211301836224 BLISTER PACK in 1 CARTON (21130-183-62) / 1 TABLET in 1 BLISTER PACK
- ndc11211301838918 BLISTER PACK in 1 CARTON (21130-183-89) / 1 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A209837
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"4f555b8f-5193-e685-e063-6294a90a7ba2": {
"match": "brand_token",
"title": "SIGNATURE PAIN RELIEF CREAM (4% LIDOCAINE) CREAM [SHENGNAN (GUANGZHOU) COSMETICS CO., LTD]",
"spl_version": "1",
"published_date": "2026-04-14"
}
},
"productid": "21130-183_22865692-fb31-425b-ac78-2d3cd7998c04",
"productndc": "21130-183",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209837",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "Sep 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "signature care anti diarrheal anti gas",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209837",
"marketing_category": "ANDA",
"nonproprietary_name": "loperamide hydrochloride, simethicone",
"start_marketing_date": "20181010",
"active_numerator_strength": "125; 2"
}Related drugs
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