🇺🇸
United States · US · US:50580-434_21abbf03-2010-4650-e063-6294a90a6edb
Sudafed Sinus 12 Hour Pressure plus Pain
Orange BookUNIISPLATC G02CC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeG02CC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150580434012 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A076518
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9TN87S3A3C",
"rxcui": "142442",
"inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
"display_name": "NAPROXEN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"67428f4b-28be-4682-a9a9-781bf85089ff": {
"match": "brand_token",
"title": "SUDAFED PE SINUS PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [SPORTPHARM LLC]",
"spl_version": "1",
"published_date": "2026-03-12"
}
},
"productid": "50580-434_21abbf03-2010-4650-e063-6294a90a6edb",
"productndc": "50580-434",
"dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
"orange_book": {
"appl_no": "076518",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "220MG;120MG",
"product_no": "001",
"approval_date": "Mar 17, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Sudafed Sinus 12 Hour Pressure plus Pain",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA076518",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen sodium and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20190617",
"active_numerator_strength": "220; 120"
}Related drugs
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- 🇺🇸Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and HeadacheAurohealth LLC
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