Allergy Relief

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBETTER LIVING BRANDS, LLC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
2113071203
1 BOTTLE in 1 CARTON (21130-712-03) / 30 TABLET in 1 BOTTLE
ndc11
2113071212
1 BOTTLE in 1 CARTON (21130-712-12) / 120 TABLET in 1 BOTTLE
ndc11
2113071246
1 BLISTER PACK in 1 CARTON (21130-712-46) / 14 TABLET in 1 BLISTER PACK
ndc11
2113071258
1 BOTTLE in 1 CARTON (21130-712-58) / 45 TABLET in 1 BOTTLE
ndc11
2113071281
2 BOTTLE in 1 CARTON (21130-712-81) / 90 TABLET in 1 BOTTLE (21130-712-09)

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A078933

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "21130-712_38a06b8a-bd81-4696-e063-6294a90a1f38",
  "productndc": "21130-712",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078933",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jun 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jun 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jun 15, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078933",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20230531",
  "active_numerator_strength": "10"
}

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