🇺🇸
United States · US · US:69168-461_597ef1fc-5ca5-4a06-958c-e2ddc6b6de84
Pain Relief
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllegiant Health
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116916846103250 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-03)
- ndc116916846117300 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-17)
- ndc116916846132100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-32)
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": {
"bad8ac0a-518d-4639-9b92-a39e0d437238": {
"match": "brand_token",
"title": "PAIN AND FEVER CHEWABLES CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
"spl_version": "2",
"published_date": "2026-05-28"
}
},
"productid": "69168-461_597ef1fc-5ca5-4a06-958c-e2ddc6b6de84",
"productndc": "69168-461",
"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": "Pain Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211544",
"marketing_category": "ANDA",
"nonproprietary_name": "Pain Relief",
"start_marketing_date": "20240424",
"active_numerator_strength": "650"
}Related drugs
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