Home NDC 49873-109 Stonarhini
Product NDC 49873-109
11-digit product format 498730109
Labeler code 49873
Product ID 49873-109_57efd45d-4dbc-5531-e063-6294a90a1c50
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, phenylephrine
Dosage form TABLET
Route ORAL
Labeler Sato Pharmaceutical Co., Ltd.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2001-11-16
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2; 5 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Stonarhini
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1242240 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49873-109-01 Stonarhini 4 in 1 CARTON TABLET 4 6 49873-109-01 Stonarhini 6 in 1 BLISTER PACK TABLET 6 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 HYDROXYPROPYL CELLULOSE (TYPE EL) INACTIVE INGREDIENT 8VAB711C5E STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49873-109 STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.] 6 Current NDC, Legacy NDC, 2 package rows 20250112_cc353280-0b4c-418c-93fe-850125955009.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49873-109-01 49873010901 4 BLISTER PACK in 1 CARTON (49873-109-01) / 6 TABLET in 1 BLISTER PACK 4 blister pack 2001-11-16 0000-00-00 No No Current