🇺🇸
United States · US · US:58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold
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 · 3
- ndc1158602816672 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602816723 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602816831 BLISTER PACK in 1 CARTON (58602-816-83) / 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": "58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531",
"productndc": "58602-816",
"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 Cold",
"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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- 🇺🇸Leader All Day Sinus and Cold DCardinal Health 110, LLC. dba Leader
- GBNaproxen 500mg / Esomeprazole 20mg modified-release tabletsColorama Pharmaceuticals Ltd
- 🇺🇸NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUSVESPYR BRANDS LLC
- 🇺🇸Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and HeadacheAurohealth LLC
- 🇺🇸Sinus and Cold DCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
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