careone tussin dm

Product NDC: 41520-826
11-digit product format: 415200826
Labeler code: 41520
Product ID: 41520-826_30dc798f-86a8-424b-b283-df0ceea7bd31
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: American Sales Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-10-22
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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: careone tussin dm
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/20mL
DOXYLAMINE SUCCINATE	12.5 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115329	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
954fe703-9a10-4354-8b71-4d98a22a0b9f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-826-26	careone tussin dm	1 in 1 CARTON	SOLUTION	1		2
41520-826-26	careone tussin dm	118 mL in 1 BOTTLE	SOLUTION	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-826	CAREONE TUSSIN DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [AMERICAN SALES COMPANY]	2	Current NDC, Legacy NDC, 2 package rows	20241116_954fe703-9a10-4354-8b71-4d98a22a0b9f.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 134 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	177e3247-402d-98e4-e063-6294a90ae068	2024-11-26	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu, CVP	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET	Lil' Drug Store Products, Inc.	e7a27773-69d6-9e07-e053-2a95a90af8ea	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	4361912e-4b56-4743-b11d-acfb94482a2e	2024-11-25	Warnings	Exact identifier application number: M012
NightTime Sinus Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	413d82d3-a896-4f15-9fca-c1b7b9a1ee63	2024-11-25	Warnings	Exact identifier application number: M012
Night Cold Flu Cough and Allergy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0	2024-11-25	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	cbd3a905-1c41-4cb0-8df6-36784430d627	2024-11-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	7a28d0fe-0e0a-453a-b604-1cc784dd153c	2024-11-25	Warnings	Exact identifier application number: M012
Cough and Cold plus	ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	c483d88f-cb0a-4dd6-b3ae-559521782ba6	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Sinus	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	a0b01aef-4248-4d41-862c-0c8884dfca5e	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	3af20739-6794-42e0-b404-3f0401d10a6d	2024-11-25	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.	ffc7e1e2-b664-461b-963d-764bad2f983f	2024-11-25	Warnings	Exact identifier application number: M012
NightTime Sinus	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	0f3b1404-9252-470a-aa8c-b360c85731f3	2024-11-25	Warnings	Exact identifier application number: M012
Maximum Strength-Cough and Chest Congestion DM	MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	d1830989-fe82-4f08-8618-78979fcef568	2024-11-25	Warnings	Exact identifier application number: M012
ASP Daytime PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b84f2392-0b24-4af0-80f7-c45454093f51	2024-11-25	Warnings	Exact identifier application number: M012
ASP Nighttime Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	d8756d1f-baf5-412d-a493-a1c051eae302	2024-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	508a65ee-42fa-4c0b-b24d-9faac6b0eba7	2024-11-24	Warnings	Exact identifier application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	cb68eef0-b027-4bf1-b78f-f31844a8c06c	2024-11-22	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	de2a64ce-c169-4162-b79e-d3809bea2147	2024-11-22	Warnings	Exact identifier application number: M012
12 Hour Nasal Decongestant Extra Moisturizing	NASAL SPRAY	WinCo Foods LLC	13fbde45-958c-455f-b766-f6a34342ee95	2024-11-21	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a01abac3-c13e-40f2-ae98-34bd6c9b7504	2024-11-21	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	954fe703-9a10-4354-8b71-4d98a22a0b9f	2
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	954fe703-9a10-4354-8b71-4d98a22a0b9f	2
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	954fe703-9a10-4354-8b71-4d98a22a0b9f	2
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	954fe703-9a10-4354-8b71-4d98a22a0b9f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-826-26	41520082626	1 BOTTLE in 1 CARTON (41520-826-26) / 118 mL in 1 BOTTLE	1 bottle	2018-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Tussin DM Drug Facts	American Sales Company	2024-11-13	HUMAN OTC DRUG LABEL	2