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United States · US · US:69729-137_26f56cb7-be59-a0c2-e063-6294a90a15fa
Pentrexcilina Day time
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOPMX LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11697291371414 TABLET in 1 BOTTLE (69729-137-14)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209274
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": {
"e11e5c17-28f2-7186-e053-2995a90a51f6": {
"match": "brand_token",
"title": "PENTREXCILINA NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [OPMX LLC]",
"spl_version": "3",
"published_date": "2025-07-21"
}
},
"productid": "69729-137_26f56cb7-be59-a0c2-e063-6294a90a15fa",
"productndc": "69729-137",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209274",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Dec 22, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Pentrexcilina Day time",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209274",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20241115",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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