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United States · US · US:0573-2919_463eea99-6d71-9757-e063-6294a90a668f

PREPARATION H

UNIISPLATC R01AA04

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeR01AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0573291912
    12 BLISTER PACK in 1 CARTON (0573-2919-12) / 1 SUPPOSITORY in 1 BLISTER PACK
  • ndc11
    0573291924
    24 BLISTER PACK in 1 CARTON (0573-2919-24) / 1 SUPPOSITORY in 1 BLISTER PACK
  • ndc11
    0573291948
    48 BLISTER PACK in 1 CARTON (0573-2919-48) / 1 SUPPOSITORY in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "04JA59TNSJ",
    "rxcui": "8164",
    "inchikey": "OCYSGIYOVXAGKQ-FVGYRXGTSA-N",
    "display_name": "PHENYLEPHRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RECTAL",
  "spl_meta": {
    "485437a8-b2e9-4acf-a20e-edb1f08a9cae": {
      "match": "brand_token",
      "title": "PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES (WITCH HAZEL) CLOTH [HALEON US HOLDINGS LLC]",
      "spl_version": "5",
      "published_date": "2026-05-13"
    }
  },
  "productid": "0573-2919_463eea99-6d71-9757-e063-6294a90a668f",
  "productndc": "0573-2919",
  "dosage_form": "SUPPOSITORY",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "PREPARATION H",
  "active_ingred_unit": "mg/1",
  "application_number": "M015",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Phenylephrine hydrochloride",
  "start_marketing_date": "20250430",
  "active_numerator_strength": "6.25"
}

Related drugs

Other records sharing ATC code R01AA04.

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