Stona

Product NDC: 49873-114
11-digit product format: 498730114
Labeler code: 49873
Product ID: 49873-114_0b3faa58-6fca-f550-e063-6394a90ad361
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sato Pharmaceutical Co., Ltd.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-09-29
Substance: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 162.5; 2; 10; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	49873-114-90	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	49873-114-90	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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: Stona
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	162.5 mg/1
CHLORPHENIRAMINE MALEATE	2 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
V1Q0O9OJ9Z	Internal UNII lookup
9D2RTI9KYH	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
1245169	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
8b89f50d-88f8-4773-92ea-5ada61766056	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49873-114-01	Stona	1 in 1 CARTON	TABLET	1		7
49873-114-01	Stona	24 in 1 BOTTLE	TABLET	24		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49873-114	STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	7	Current NDC, Legacy NDC, 2 package rows	20231129_8b89f50d-88f8-4773-92ea-5ada61766056.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 101 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	3f79137f-f0b0-d22c-e063-6394a90a7245	2025-09-23	Warnings	Exact identifier application number: M012
GoodSense Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	GOOD SENSE	240bb6af-9d38-49fe-9011-3016246b0986	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Honey Lemon Cough Drops	HONEY LEMON COUGH DROPS	Cintas Corporation	79e0b7c1-4acc-41d2-89cd-d075a8bac0c9	2025-09-23	Warnings	Exact identifier application number: M012
Topcare NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	b2b3c450-e988-41d1-9e53-cc8e30d75cb4	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Cherry Cough Drops	CHERRY COUGH DROPS	Cintas Corporation	d1fd2f23-5435-405d-a7fd-644691f79e80	2025-09-23	Warnings	Exact identifier application number: M012
Topcare DayTime NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	560fb22b-391f-4d7b-a6fd-38d577d404b0	2025-09-23	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f67ac3d-1503-3418-e063-6394a90a938f	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories Inc.	3f68e68a-cf32-9df8-e063-6394a90a3012	2025-09-22	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kramer Novis	f0bec5f5-4d76-471e-9024-557eba848b93	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	9f050fb0-6100-4b14-b82f-1d5fcbf16540	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	c6392ace-c7d1-4450-8b71-4dccc60b4f02	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f12ee8f-d1c6-d73a-e063-6394a90a9199	2025-09-18	Warnings	Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3d71d306-893a-e73a-e063-6394a90a0a3b	2025-09-18	Warnings	Exact identifier application number: M012
Giltuss D	GILTUSS D	Dextrum Laboratories Inc.	3f17eefb-b625-b0f2-e063-6294a90afd4d	2025-09-18	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b	2025-09-17	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories Inc	3effaf4b-28c3-6131-e063-6294a90a17ff	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	1872e1ff-2e08-c404-e063-6294a90afa14	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1323a67c-b9c5-038c-e063-6394a90a5e6b	2025-09-17	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f025ef6-79e7-e833-e063-6294a90ab501	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	186f8519-655d-bd21-e063-6294a90a16a8	2025-09-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245169	acetaminophen 163 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	8b89f50d-88f8-4773-92ea-5ada61766056	7
1245169	acetaminophen 163 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	8b89f50d-88f8-4773-92ea-5ada61766056	7
1245169	APAP 163 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	8b89f50d-88f8-4773-92ea-5ada61766056	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49873-114-01	49873011401	1 BOTTLE in 1 CARTON (49873-114-01) / 24 TABLET in 1 BOTTLE	1 bottle	2004-09-29	0000-00-00	No	No	Current