Nighttime Sleep Aid

In shortageOrange BookUNIISPLATC R06AA59

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

Identification

ManufacturerAllegiant Health

CountryUS (United States)

ATC codeR06AA59

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6916843906
120 TABLET in 1 BOTTLE (69168-439-06)
ndc11
6916843940
40 TABLET in 1 BOTTLE (69168-439-40)
ndc11
6916843984
2 BLISTER PACK in 1 CARTON (69168-439-84) / 8 TABLET in 1 BLISTER PACK
ndc11
6916843998
200 TABLET in 1 BOTTLE (69168-439-98)

Annotations

UNII (FDA Substance ID)

V9BI9B5YI2

DOXYLAMINE SUCCINATE

RxCUI 23665

Orange Book

A040564

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": {
    "2201d5c0-bd51-47a7-9775-916b18573623": {
      "match": "brand_token",
      "title": "NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [PUBLIX SUPER MARKETS INC]",
      "spl_version": "8",
      "published_date": "2026-05-25"
    }
  },
  "productid": "69168-439_8accb0e9-d994-4b6a-acc3-4b416f3f65ba",
  "productndc": "69168-439",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040564",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2004"
      }
    ],
    "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": "Nighttime Sleep Aid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040564",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nighttime Sleep Aid",
  "start_marketing_date": "20230516",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code R06AA59.

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