🇺🇸
United States · US · US:63548-0197_fbc47d79-348d-436e-ae3f-364d76f58e49
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPLD Acquisitions LLC DBA Av�ma Pharma Solutions
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1163548019721 BOTTLE, PLASTIC in 1 BOX (63548-0197-2) / 20 TABLET in 1 BOTTLE, PLASTIC
- ndc116354801973300 TABLET in 1 BOTTLE, PLASTIC (63548-0197-3)
- ndc1163548019788 TABLET in 1 BOTTLE, PLASTIC (63548-0197-8)
Annotations
UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A211404
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": "63548-0197_fbc47d79-348d-436e-ae3f-364d76f58e49",
"productndc": "63548-0197",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211404",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "38MG;200MG",
"product_no": "001",
"approval_date": "Apr 11, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
"proprietary_name": "Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211404",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen, Diphenhydramine Citrate",
"start_marketing_date": "20240411",
"active_numerator_strength": "38; 200"
}Related drugs
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