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United States · US · US:69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7
Naproxen Sodium and Diphenhydramine HCl
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1169238142221 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE
- ndc1169238142241 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE
- ndc1169238142261 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE
- ndc1169238142281 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A209726
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": "69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7",
"productndc": "69238-1422",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209726",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG;220MG",
"product_no": "001",
"approval_date": "Oct 23, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
"proprietary_name": "Naproxen Sodium and Diphenhydramine HCl",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209726",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen Sodium and Diphenhydramine",
"start_marketing_date": "20181023",
"active_numerator_strength": "25; 220"
}Related drugs
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