🇺🇸
United States · US · US:63868-003_24359048-c9f1-7f42-e063-6294a90aeaef
Severe Cold and Flu
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChain Drug Marketing Association
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163868003242 BLISTER PACK in 1 CARTON (63868-003-24) / 12 TABLET, COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
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": {
"1efd1778-7ab1-4797-98c5-4637940ee3ec": {
"match": "brand_token",
"title": "SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
"spl_version": "2",
"published_date": "2026-05-13"
}
},
"productid": "63868-003_24359048-c9f1-7f42-e063-6294a90aeaef",
"productndc": "63868-003",
"dosage_form": "TABLET, COATED",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Severe Cold and Flu",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE",
"start_marketing_date": "20120724",
"active_numerator_strength": "325; 10; 200; 5"
}Related drugs
Other records sharing ATC code N02BE.
- 🇺🇸24-7 Life BY 7-ELEVEN Nighttime Cold and FluLil' Drug Store products, Inc.
- 🇺🇸Aacetaminophen and IbuprofenGRANULES USA, INC.
- 🇺🇸AcetaminophenRAONBIO CORP
- 🇺🇸Acetaminophen , Aspirin and CaffeineSoftgel Healthcare Pvt Ltd
- 🇺🇸Acetaminophen , Caffeine and pyrilamine maleateSoftgel Healthcare Pvt Ltd
- 🇺🇸Acetaminophen , Caffeine and pyrilamine maleateSoftgel Healthcare Pvt Ltd
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgR J General Corporation
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgSun Pharmaceutical Industries, Inc.
Access this data programmatically
Query Severe Cold and Flu 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.