🇺🇸
United States · US · US:58602-832_0287563f-3472-401d-b95f-9694258def17
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache
Orange BookUNIISPLATC G02CC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeG02CC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1158602832672 BLISTER PACK in 1 CARTON (58602-832-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602832831 BLISTER PACK in 1 CARTON (58602-832-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A211360
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": {
"c5146d73-2f34-4dfe-ac29-97071279dc4d": {
"match": "brand_token",
"title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2026-05-28"
}
},
"productid": "58602-832_0287563f-3472-401d-b95f-9694258def17",
"productndc": "58602-832",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211360",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "220MG;120MG",
"product_no": "001",
"approval_date": "Jun 1, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211360",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen Sodium and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20220601",
"active_numerator_strength": "220; 120"
}Related drugs
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