🇺🇸
United States · US · US:36800-264_32352610-bdfc-40f5-8d85-daa6fc9f7ae4
topcare all night pain relief pm
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1136800264271 BOTTLE in 1 CARTON (36800-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE
- ndc1136800264601 BOTTLE in 1 CARTON (36800-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A208499
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TC2D6JAD40",
"rxcui": "1362",
"inchikey": "PCHPORCSPXIHLZ-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
"match": "brand_token",
"title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "36800-264_32352610-bdfc-40f5-8d85-daa6fc9f7ae4",
"productndc": "36800-264",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208499",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG;220MG",
"product_no": "001",
"approval_date": "May 10, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
"proprietary_name": "topcare all night pain relief pm",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA208499",
"marketing_category": "ANDA",
"nonproprietary_name": "diphenhydramine hydrochloride, naproxen sodium",
"start_marketing_date": "20190808",
"active_numerator_strength": "25; 220"
}Related drugs
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