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United States · US · US:21130-228_09fc3572-d282-478d-ba22-70690f615e65

Ibuprofen and Diphenhydramine Citrate

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerBetter Living Brands, LLC
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    2113022812
    1 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE
  • ndc11
    2113022818
    1 BOTTLE in 1 CARTON (21130-228-18) / 80 TABLET, COATED in 1 BOTTLE
  • ndc11
    2113022823
    1 BOTTLE in 1 CARTON (21130-228-23) / 120 TABLET, COATED in 1 BOTTLE
  • ndc11
    2113022873
    1 BOTTLE in 1 CARTON (21130-228-73) / 20 TABLET, COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A216204
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4OD433S209",
    "rxcui": "82004",
    "inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "aeee629b-255c-40d8-8e95-779aec00f723": {
      "match": "brand_token",
      "title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "21130-228_09fc3572-d282-478d-ba22-70690f615e65",
  "productndc": "21130-228",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "216204",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "May 31, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
  "proprietary_name": "Ibuprofen and Diphenhydramine Citrate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA216204",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and Diphenhydramine Citrate",
  "start_marketing_date": "20231115",
  "active_numerator_strength": "38; 200"
}

Related drugs

Other records sharing ATC code D04AA.

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