🇺🇸
United States · US · US:37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424
naproxen sodium pm
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH E B
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1137808264271 BOTTLE in 1 CARTON (37808-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE
- ndc1137808264601 BOTTLE in 1 CARTON (37808-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A208499
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TC2D6JAD40",
"rxcui": "1362",
"inchikey": "PCHPORCSPXIHLZ-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
"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": "37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424",
"productndc": "37808-264",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208499",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG;220MG",
"product_no": "001",
"approval_date": "May 10, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
"proprietary_name": "naproxen sodium pm",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA208499",
"marketing_category": "ANDA",
"nonproprietary_name": "diphenhydramine hydrochloride, naproxen sodium",
"start_marketing_date": "20201013",
"active_numerator_strength": "25; 220"
}Related drugs
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