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United States · US · US:55319-957_e5385990-9e94-42e7-9923-f2893d93bd34
Childrens Allergy
Orange BookUNIISPLATC R06AX26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFamily Dollar (FAMILY WELLNESS)
CountryUS (United States)
ATC codeR06AX26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155319957041 BOTTLE, PLASTIC in 1 BOX (55319-957-04) / 118 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A203330
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2S068B75ZU",
"rxcui": "236474",
"inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
"display_name": "FEXOFENADINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"436c0126-4ff3-c082-e063-6294a90a3d72": {
"match": "brand_token",
"title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "55319-957_e5385990-9e94-42e7-9923-f2893d93bd34",
"productndc": "55319-957",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "203330",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG/5ML",
"product_no": "001",
"approval_date": "Nov 18, 2014"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "30MG/5ML",
"product_no": "002",
"approval_date": "Nov 18, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FEXOFENADINE HYDROCHLORIDE",
"proprietary_name": "Childrens Allergy",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA203330",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine HCL",
"start_marketing_date": "20231031",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code R06AX26.
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