🇺🇸
United States · US · US:50580-576_21acd9d2-84aa-3a95-e063-6394a90af438
TYLENOL 8 HR MUSCLE ACHES AND PAIN
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150580576011 BOTTLE in 1 CARTON (50580-576-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
- ndc1150580576021 BOTTLE in 1 CARTON (50580-576-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
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": {
"1622f694-4d63-4c56-8737-fae31f0ecfb7": {
"match": "brand_token",
"title": "TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [KENVUE BRANDS LLC]",
"spl_version": "13",
"published_date": "2026-05-28"
}
},
"productid": "50580-576_21acd9d2-84aa-3a95-e063-6394a90af438",
"productndc": "50580-576",
"dosage_form": "TABLET, FILM COATED, 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": "TYLENOL 8 HR MUSCLE ACHES AND PAIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211544",
"marketing_category": "ANDA",
"nonproprietary_name": "acetaminophen",
"start_marketing_date": "20240130",
"active_numerator_strength": "650"
}Related drugs
Other records sharing ATC code N02BE51.
- 🇺🇸365 whole foods market acetaminophenWhole Foods Market, INC.
- 🇺🇸8 Hour Arthritis PainCHAIN DRUG MARKETING ASSOCIATION, INC.
- 🇺🇸8 Hour Arthritis PainMARC GLASSMAN, INC.
- 🇺🇸8 Hour Arthritis PainAMERISOURCE BERGEN
- 🇺🇸8 Hour Arthritis PainVALU MERCHANDISERS COMPANY
- 🇺🇸8 Hour Pain ReliefVALU MERCHANDISERS COMPANY
- 🇺🇸8 Hour Pain ReliefKROGER COMPANY
- 🇺🇸8 Hour Pain ReliefCHAIN DRUG MARKETING ASSOCIATION, INC.
Access this data programmatically
Query TYLENOL 8 HR MUSCLE ACHES AND PAIN and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.