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United States · US · US:56062-441_2fbd1f60-92db-4bba-ae73-36d0e3c3a8c5

sleep aid

In shortageOrange BookUNIISPLATC R06AA59

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

Identification

ManufacturerPublix Super Markets Inc
CountryUS (United States)
ATC codeR06AA59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5606244101
    1 BOTTLE in 1 CARTON (56062-441-01) / 96 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A040167
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release
Raw payload (JSON)
{
  "unii": {
    "unii": "V9BI9B5YI2",
    "rxcui": "23665",
    "inchikey": "KBAUFVUYFNWQFM-UHFFFAOYSA-N",
    "display_name": "DOXYLAMINE SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4b5fdb06-f205-4424-b4cb-dddef921485b": {
      "match": "brand_token",
      "title": "SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [RITE AID CORPORATION]",
      "spl_version": "4",
      "published_date": "2026-05-28"
    }
  },
  "productid": "56062-441_2fbd1f60-92db-4bba-ae73-36d0e3c3a8c5",
  "productndc": "56062-441",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040167",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Sep 18, 1996"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DOXYLAMINE SUCCINATE",
  "shortage_reason": "Doxylamine Succinate and Pyridoxine  Hydrochloride Tablet, Delayed Release",
  "shortage_status": "current",
  "proprietary_name": "sleep aid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040167",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxylamine succinate",
  "start_marketing_date": "20250516",
  "active_numerator_strength": "25"
}

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