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United States · US · US:0316-0284_3bdcb3d7-164d-e678-e063-6394a90a3d6b

PanOxyl

Orange BookUNIISPLATC D10AD53

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCROWN LABORATORIES
CountryUS (United States)
ATC codeD10AD53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0316028415
    1 TUBE in 1 CARTON (0316-0284-15) / 15 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A215940
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1L4806J2QF",
    "rxcui": "60223",
    "inchikey": "LZCDAPDGXCYOEH-UHFFFAOYSA-N",
    "display_name": "ADAPALENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "507150a0-9c20-4a2e-e063-6394a90ab9c7": {
      "match": "brand_token",
      "title": "PANOXYL ACNE CLEARING SPOT TREATMENT (BENZOYL PEROXIDE) GEL [CROWN LABORATORIES]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "0316-0284_3bdcb3d7-164d-e678-e063-6394a90a3d6b",
  "productndc": "0316-0284",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "215940",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Jan 14, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ADAPALENE",
  "proprietary_name": "PanOxyl",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA215940",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Adapalene",
  "start_marketing_date": "20250808",
  "active_numerator_strength": "1"
}

Related drugs

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