🇺🇸
United States · US · US:63868-679_24357a94-9aa7-4606-e063-6294a90ad492
8 Hour Pain Relief
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCHAIN DRUG MARKETING ASSOCIATION INC
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163868679501 BOTTLE, PLASTIC in 1 CARTON (63868-679-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211544
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": "63868-679_24357a94-9aa7-4606-e063-6294a90ad492",
"productndc": "63868-679",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211544",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Apr 16, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "8 Hour Pain Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211544",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen",
"start_marketing_date": "20200801",
"active_numerator_strength": "650"
}Related drugs
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