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United States · US · US:51316-354_33d1710e-b90e-c820-e063-6394a90aaf15

8 HR MUSCLE ACHES AND PAIN

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131635442
    1 BOTTLE in 1 CARTON (51316-354-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A215486
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d11a7412-a543-0e34-e053-2995a90afd63": {
      "match": "brand_token",
      "title": "8 HOUR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]",
      "spl_version": "5",
      "published_date": "2025-12-12"
    }
  },
  "productid": "51316-354_33d1710e-b90e-c820-e063-6394a90aaf15",
  "productndc": "51316-354",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215486",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Aug 25, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "8 HR MUSCLE ACHES AND PAIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215486",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20250625",
  "active_numerator_strength": "650"
}

Related drugs

Other records sharing ATC code N02BE51.

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