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United States · US · US:51316-616_00329fc8-144a-4254-8482-87adab8d9685
sinus and nasal decongestant
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11513166165210 BLISTER PACK in 1 CARTON (51316-616-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11513166166020 BLISTER PACK in 1 CARTON (51316-616-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A075153
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6V9V2RYJ8N",
"rxcui": "91168",
"inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
"display_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e9dd2d7b-0a19-4a42-b51e-b9914f02406e": {
"match": "brand_token",
"title": "SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]",
"spl_version": "15",
"published_date": "2026-05-25"
}
},
"productid": "51316-616_00329fc8-144a-4254-8482-87adab8d9685",
"productndc": "51316-616",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075153",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Feb 26, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "sinus and nasal decongestant",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075153",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine Hydrochloride",
"start_marketing_date": "20260120",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
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