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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

  • ndc11
    6220781438
    37500 TABLET, FILM COATED in 1 POUCH (62207-814-38)
  • ndc11
    6220781439
    7500 TABLET, FILM COATED in 1 POUCH (62207-814-39)
  • ndc11
    6220781447
    500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47)
  • ndc11
    6220781495
    1 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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