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 56 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	ca3c1eb4-6099-5e5f-e053-2995a90ab61b	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	fe6dff90-18f1-491e-84b9-cc74bb1831ba	2026-01-19	Warnings	Exact identifier application number: M012
Daytime Non-Drowsy Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens Company	ec8c73d5-b190-432a-92c6-68ea0fc86ea6	2026-01-19	Warnings	Exact identifier application number: M012
Walgreens NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREEN COMPANY	5bf72e2f-15c8-466a-9e13-50654233da91	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	9862f84d-1c18-4ef7-86dc-98572599d417	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	37853689-c9ca-4bc7-9c5b-4a68b8d778be	2026-01-19	Warnings	Exact identifier application number: M012
VAPORX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	AKRON PHARMA INC	51b32162-0c5a-4b5b-999a-34337d816603	2026-01-19	Warnings	Exact identifier application number: M012
Equate	OXYMETAZOLINE HCL	Walmart Inc	2f762c24-2442-506a-e063-6394a90a3b96	2026-01-19	Warnings	Exact identifier application number: M012
Dimetane	DIPHENHYDRAMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	2026-01-19	Warnings	Exact identifier application number: M012
nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	f681d986-9838-42d8-8ed9-732a39fbf870	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	H E B	22d241c5-a3fd-4619-8147-91d7a4c8cf98	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Better Living Brands, LLC	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	2026-01-19	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	5749ce9d-e182-478f-ab88-b520a35a99a7	2026-01-19	Warnings	Exact identifier application number: M012
Foster and Thrive Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	1d9150b1-2f6c-4c33-8c93-3ed1d88585e2	2026-01-18	Warnings	Exact identifier application number: M012
HealthWise Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	ce3ceffd-3ff5-3795-e053-2995a90a827f	2026-01-18	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	31210a95-f9dc-49db-aab5-25c4dca49266	2026-01-17	Warnings	Exact identifier application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f77226c0-b6d5-9fd0-e053-6294a90a4b57	2026-01-16	Warnings	Exact identifier application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f691734b-5cf4-6eb8-e053-2a95a90aee80	2026-01-16	Warnings	Exact identifier application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f771aa19-295a-9f4e-e053-6294a90a1674	2026-01-16	Warnings	Exact identifier application number: M012
CVS Cherry Cough Drops	MENTHOL	CVS Pharmacy	de5c4b94-0420-5d43-e053-2995a90aa5a5	2026-01-16	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