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United States · US · US:68682-132_18705773-78c3-4eac-a1a7-f4ac6f667ef2

Clindamycin Phosphate and Benzoyl Peroxide

Orange BookUNIISPLATC D10AF

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

Identification

ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeD10AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6868213250
    1 BOTTLE, PUMP in 1 CARTON (68682-132-50) / 50 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
W9WZN9A0GM
BENZOYL PEROXIDE
RxCUI 1418
Orange Book
N050819
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "W9WZN9A0GM",
    "rxcui": "1418",
    "inchikey": "OMPJBNCRMGITSC-UHFFFAOYSA-N",
    "display_name": "BENZOYL PEROXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "27747e01-85eb-44de-a4a6-711a7799218a": {
      "match": "brand_token",
      "title": "CLINDAMYCIN PHOSPHATE SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "111",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68682-132_18705773-78c3-4eac-a1a7-f4ac6f667ef2",
  "productndc": "68682-132",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "050819",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5%;EQ 1.2% BASE",
        "product_no": "001",
        "approval_date": "Oct 23, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3.75%;EQ 1.2% BASE",
        "product_no": "002",
        "approval_date": "Nov 24, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE",
  "proprietary_name": "Clindamycin Phosphate and Benzoyl Peroxide",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "NDA050819",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Clindamycin Phosphate and Benzoyl Peroxide",
  "start_marketing_date": "20180702",
  "active_numerator_strength": "25; 10"
}

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