revivol-xr

Generic: phenylephrine hydrochloride

Labeler: unipack llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name revivol-xr
Generic Name phenylephrine hydrochloride
Labeler unipack llc
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

phenylephrine hydrochloride 6.25 mg/1

Manufacturer
Unipack LLC

Identifiers & Regulatory

Product NDC 43749-432
Product ID 43749-432_39db2684-3085-e26e-e063-6394a90ae422
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2025-04-01

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43749432
Hyphenated Format 43749-432

Supplemental Identifiers

UPC
0850012509271
UNII
04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name revivol-xr (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (43749-432-01) / 1 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (1)

43749-432-01 24 BLISTER PACK in 1 CARTON (43749-432-01) / 1 SUPPOSITORY in 1 BLISTER PACK

Ingredients (1)

phenylephrine hydrochloride (6.25 mg/1)

Linked Drug Pages (1)

ReVIVOL-XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "39db2684-3085-e26e-e063-6394a90ae422", "openfda": {"upc": ["0850012509271"], "unii": ["04JA59TNSJ"], "spl_set_id": ["2950fe83-a2a4-4ed4-b645-69d6fd2381ae"], "manufacturer_name": ["Unipack LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (43749-432-01)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "43749-432-01", "marketing_start_date": "20250401"}], "brand_name": "ReVIVOL-XR", "product_id": "43749-432_39db2684-3085-e26e-e063-6394a90ae422", "dosage_form": "SUPPOSITORY", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "43749-432", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Unipack LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ReVIVOL-XR", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "6.25 mg/1"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250401", "listing_expiration_date": "20261231"}