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United States · US · US:76162-134_1396fed3-16fb-421a-89c5-4dd83706cd41
topcare allergy
Orange BookUNIISPLATC D07AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeD07AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1176162134021 BOTTLE, SPRAY in 1 CARTON (76162-134-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
- ndc1176162134111 BOTTLE, SPRAY in 1 CARTON (76162-134-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
MTW0WEG809
MOMETASONE FUROATE MONOHYDRATE
RxCUI 153374
Orange Book
N215712
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MTW0WEG809",
"rxcui": "153374",
"inchikey": "AQCCVUHZMIMSIB-HRVPQZBTSA-N",
"display_name": "MOMETASONE FUROATE MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
"match": "brand_token",
"title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "76162-134_1396fed3-16fb-421a-89c5-4dd83706cd41",
"productndc": "76162-134",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "215712",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.05MG/SPRAY",
"product_no": "001",
"approval_date": "Mar 17, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "MOMETASONE FUROATE MONOHYDRATE",
"proprietary_name": "topcare allergy",
"active_ingred_unit": "ug/1",
"application_number": "NDA215712",
"marketing_category": "NDA",
"nonproprietary_name": "mometasone furoate monohydrate",
"start_marketing_date": "20230328",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code D07AC13.
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