🇺🇸
United States · US · US:51316-504_429c1da2-954d-412d-9065-bb67ebbdf3aa
8 hr arthritis pain
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115131650479400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51316-504-79)
- ndc115131650483225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51316-504-83)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A075077
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d11a7412-a543-0e34-e053-2995a90afd63": {
"match": "brand_token",
"title": "8 HOUR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]",
"spl_version": "5",
"published_date": "2025-12-12"
}
},
"productid": "51316-504_429c1da2-954d-412d-9065-bb67ebbdf3aa",
"productndc": "51316-504",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075077",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Feb 25, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "8 hr arthritis pain",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075077",
"marketing_category": "ANDA",
"nonproprietary_name": "acetaminophen",
"start_marketing_date": "20250929",
"active_numerator_strength": "650"
}Related drugs
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