🇺🇸
United States · US · US:50580-309_21e84490-8cad-bf34-e063-6394a90af940
Tylenol 8HR
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
- ndc1150580309011 BOTTLE in 1 CARTON (50580-309-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
- ndc1150580309021 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N019872
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": "50580-309_21e84490-8cad-bf34-e063-6394a90af940",
"productndc": "50580-309",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "019872",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Jun 8, 1994"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "650MG",
"product_no": "002",
"approval_date": "Jan 11, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "Tylenol 8HR",
"active_ingred_unit": "mg/1",
"application_number": "NDA019872",
"marketing_category": "NDA",
"nonproprietary_name": "acetaminophen",
"start_marketing_date": "20160118",
"active_numerator_strength": "650"
}Related drugs
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