🇺🇸
United States · US · US:51316-354_33d1710e-b90e-c820-e063-6394a90aaf15
8 HR MUSCLE ACHES AND PAIN
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151316354421 BOTTLE in 1 CARTON (51316-354-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A215486
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": "51316-354_33d1710e-b90e-c820-e063-6394a90aaf15",
"productndc": "51316-354",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215486",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Aug 25, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "8 HR MUSCLE ACHES AND PAIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215486",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen",
"start_marketing_date": "20250625",
"active_numerator_strength": "650"
}Related drugs
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