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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cc353280-0b4c-418c-93fe-850125955009	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

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
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 84 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	9c8c1974-f931-4493-abb5-ecdc32764ab3	2025-12-02	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	770c0e4f-0eed-4b8c-85a5-761b6a84db62	2025-12-02	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WAL-MART STORES INC	a2a7e568-bff8-4818-a31d-7c2efa1859c3	2025-12-02	Warnings	Exact identifier application number: M012
DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET	Lil' Drug Store Products, Inc.	44fa0193-2a19-bdc1-e063-6394a90a60e8	2025-12-02	Warnings	Exact identifier application number: M012
Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44fb9958-d771-f4b3-e063-6294a90a9135	2025-12-02	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	f1a73da7-0dbb-49bd-857e-7dd6bc11b63c	2025-12-02	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	ac74be47-30f0-418b-bd07-502feaa9723f	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens High Blood Pressure Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN	WALGREENS CO.	bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen High Blood Pressure Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Nighttime Kids Honey Cold Cough Congestion	DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO	c0f317cd-723d-47f2-b600-aaeae6399482	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen Maximum Strength Severe Congestion and cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALGREENS CO.	b4abcb6d-f3e1-4d63-98cf-ff556ec423b6	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Daytime Childrens	COUGH AND CHEST CONGESTION	WALGREENS CO.	dd99675f-3860-42ef-999c-d9a3746a38c0	2025-12-01	Warnings	Exact identifier application number: M012
Adult Cough plus Chest Congestion DM with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	WALGREEN COMPANY	5f5af13a-c2a3-4bbe-880e-9c57b36e9234	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREEN COMPANY	b2e08f4d-9753-4767-a8eb-3740dd1034cc	2025-12-01	Warnings	Exact identifier application number: M012
WALGREENS Cold Cough and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	1e903034-942e-4c6e-9f96-eb097c266580	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens DAY and NIGHT PACK	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	WALGREEN CO	cb87e57b-ff06-4973-9751-137c7021e272	2025-12-01	Warnings	Exact identifier application number: M012
WALGREEN Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	WALGREENS CO.	b7b1d604-921d-4ae7-93de-dcf690d421b4	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	235b2866-bbda-7148-e063-6394a90a898f	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	32352109-31dc-8e6f-e063-6294a90a2f92	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	323347c3-d51a-4976-e063-6294a90a952e	2025-12-01	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1242240	chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	cc353280-0b4c-418c-93fe-850125955009	6
1242240	chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	cc353280-0b4c-418c-93fe-850125955009	6

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