🇺🇸
United States · US · US:62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765
Naproxen Sodium and Diphenhydramine HCl
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGranules India Ltd
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11622078143837500 TABLET, FILM COATED in 1 POUCH (62207-814-38)
- ndc1162207814397500 TABLET, FILM COATED in 1 POUCH (62207-814-39)
- ndc116220781447500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47)
- ndc1162207814951 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A213663
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": "62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765",
"productndc": "62207-814",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213663",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG;220MG",
"product_no": "001",
"approval_date": "Sep 24, 2020"
}
],
"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": "ANDA213663",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen Sodium and Diphenhydramine HCl",
"start_marketing_date": "20210220",
"active_numerator_strength": "25; 220"
}Related drugs
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