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United States · US · US:68094-004_16b6f804-4056-45a4-8764-8ca4256b3b43
Dye Free Childrens Cetirizine Hydrocholride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrecision Dose, Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168094004623 TRAY in 1 CASE (68094-004-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A204226
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "64O047KTOA",
"rxcui": "203150",
"inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
"display_name": "CETIRIZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"46846abe-062d-a11f-e063-6294a90a73f3": {
"match": "brand_token",
"title": "DYE FREE REGULAR STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [WALMART INC.]",
"spl_version": "2",
"published_date": "2026-02-26"
}
},
"productid": "68094-004_16b6f804-4056-45a4-8764-8ca4256b3b43",
"productndc": "68094-004",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "204226",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Sep 9, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Dye Free Childrens Cetirizine Hydrocholride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA204226",
"marketing_category": "ANDA",
"nonproprietary_name": "cetirizine hcl",
"start_marketing_date": "20161026",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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