🇺🇸
United States · US · US:75907-158_ac5bcacf-74a8-2803-2157-fa190e092558
Dual Action
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117590715814144 TABLET, FILM COATED in 1 BOTTLE (75907-158-14)
- ndc117590715825250 TABLET, FILM COATED in 1 BOTTLE (75907-158-25)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A218247
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
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": {
"8d9a0c56-ef22-45a6-8b1d-d2b2f3247210": {
"match": "brand_token",
"title": "DUAL ACTION BACK PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [MEIJER, INC.]",
"spl_version": "2",
"published_date": "2026-03-23"
}
},
"productid": "75907-158_ac5bcacf-74a8-2803-2157-fa190e092558",
"productndc": "75907-158",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218247",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;125MG",
"product_no": "001",
"approval_date": "Aug 23, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; IBUPROFEN",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Dual Action",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA218247",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/ 125 mg",
"start_marketing_date": "20250206",
"active_numerator_strength": "250; 125"
}Related drugs
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