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United States · US · US:36800-054_1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6
topcare 12 hour decongestant
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11368000545210 BLISTER PACK in 1 CARTON (36800-054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11368000546020 BLISTER PACK in 1 CARTON (36800-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A075153
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6V9V2RYJ8N",
"rxcui": "91168",
"inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
"display_name": "PSEUDOEPHEDRINE 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": "36800-054_1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6",
"productndc": "36800-054",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075153",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Feb 26, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "topcare 12 hour decongestant",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075153",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine Hydrochloride",
"start_marketing_date": "20000425",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
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