Capmist DM

Product NDC: 29978-601
11-digit product format: 299780601
Labeler code: 29978
Product ID: 29978-601_45134129-e509-ebf0-e063-6294a90a03cd
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Capital Pharmaceutical, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-06-20
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 15; 400; 60 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	29978-601		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	29978-601	29978-601-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	29978-601	29978-601-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: Capmist DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
GUAIFENESIN	400 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1426660	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
63733ac3-859e-4a8e-8717-d852bd303408	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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
29978-601-30	2025-12-03	Capmist DM Tablets
29978-601-90	2025-12-03	Capmist DM Tablets
29978-601-30	2025-07-29	Capmist DM Tablets
29978-601-90	2025-07-29	Capmist DM Tablets
29978-601-30	2020-03-12	Capmist DM Tablets
29978-601-90	2020-03-12	Capmist DM Tablets
29978-601-30	2020-01-31	Capmist DM Tablets
29978-601-90	2020-01-31	Capmist DM Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29978-601-30	Capmist DM	2 in 1 BOX	TABLET	2	9
29978-601-30	Capmist DM	15 in 1 BLISTER PACK	TABLET	15	9
29978-601-90	Capmist DM	90 in 1 BOTTLE	TABLET	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29978-601-90	EA - Each	29978-601	257bd348-59df-4765-a2b5-f60c025e81f2	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29978-601	CAPMIST DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]	8	Current NDC, Legacy NDC, 3 package rows	20241201_63733ac3-859e-4a8e-8717-d852bd303408.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 115 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussin DM Sugar free	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AARNA USA, Inc.	3a521b65-fb35-4cc3-b826-88513afda0f9	2025-05-16	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	51c7628a-c7cf-498f-8fb1-db732e2b8b6e	2025-05-16	Warnings	Exact identifier application number: M012
BACTIMICINA CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	DLC Laboratories, Inc.	eaf554d4-a758-4ed6-bec5-d6cbfedae408	2025-05-15	Warnings	Exact identifier application number: M012
Bactimicina Childrens Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	DLC Laboratories, Inc.	d407a583-07ae-4d47-b15a-24b5865c82da	2025-05-15	Warnings	Exact identifier application number: M012
Mucinex Nightshift Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	RB Health (US) LLC	35322238-d498-1a52-e063-6394a90ac9c4	2025-05-15	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	a1405038-80f2-45e5-bd8c-8c6b0ee348be	2025-05-15	Warnings	Exact identifier application number: M012
Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	b919f0fe-fae0-4bd8-9ccd-d7569b2a7070	2025-05-13	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	2025-05-13	Warnings	Exact identifier application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	77be57fb-0ae5-4fad-97f3-b6a4b57383a9	2025-05-13	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	c948e612-a491-4ad0-adb9-cf31ef76e4d8	2025-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	c3d0b70f-d213-4e38-88ab-1c89d93a391d	2025-05-10	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Safeway, Inc.	c639a36d-c683-4a4d-90b7-eadec7464aa2	2025-05-08	Warnings	Exact identifier application number: M012
Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645	2025-05-07	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	2b962d87-6ff5-4c0f-8504-e5b61c940612	2025-05-05	Warnings	Exact identifier application number: M012
Cough and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID	CVS	2d13564a-e8d1-c357-e063-6394a90ad90e	2025-05-02	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33fe0e49-3de5-8afd-e063-6294a90a0ad5	2025-05-02	Warnings	Exact identifier application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy, Inc.	2d13964a-8cc4-f3dc-e063-6394a90aa105	2025-05-02	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	AARNA USA INC.	32c26835-f54e-d7e5-e063-6294a90ae1c0	2025-04-30	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33e6239b-364a-0e62-e063-6294a90a5047	2025-04-29	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS Pharmacy	8296049c-72fc-4200-9d45-c8e377314cf2	2025-04-29	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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1426660	dextromethorphan HBr 15 MG / guaiFENesin 400 MG / pseudoephedrine HCl 60 MG Oral Tablet	PSN	63733ac3-859e-4a8e-8717-d852bd303408	9
1426660	dextromethorphan hydrobromide 15 MG / guaifenesin 400 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	SCD	63733ac3-859e-4a8e-8717-d852bd303408	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29978-601-30	29978060130	2 BLISTER PACK in 1 BOX (29978-601-30) / 15 TABLET in 1 BLISTER PACK	2 blister pack	2013-06-20	0000-00-00	No	No	Current
29978-601-90	29978060190	90 TABLET in 1 BOTTLE (29978-601-90)	90 tablet	2013-06-20	0000-00-00	No	No	Current