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 100 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rompe Pecho CF	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	401a97af-36ae-4e54-e063-6294a90ab3ee	2025-10-01	Warnings	Exact identifier application number: M012
NyQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	724d0889-5ba5-3125-e053-2a91aa0a92c1	2025-10-01	Warnings	Exact identifier application number: M012
DayQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	724f2833-34bd-6a9e-e053-2991aa0a073d	2025-10-01	Warnings	Exact identifier application number: M012
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	InvaTech Pharma Solutions LLC	b8d360fa-0d80-f6a8-e053-2a95a90a8bd4	2025-10-01		Exact identifier application number: M012
LEADER TUSSIN CF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	f4ffe87b-0a62-44ac-b84a-08cf77cda7f5	2025-10-01	Warnings	Exact identifier application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-Eleven	OXYMETAZOLINE HCL NASAL SOLUTION 0.05%	Lil' Drug Store Products, Inc.	3e781417-9ffc-f2c9-e063-6294a90a7205	2025-09-30	Warnings	Exact identifier application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf	2025-09-30	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3ff240ba-90b2-4c17-e063-6394a90ac56f	2025-09-29	Warnings	Exact identifier application number: M012
Dometuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	3fcace53-a81f-e774-e063-6294a90a32fa	2025-09-27	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	f6a3680a-3ac6-4fd4-be52-ce29064c4aa1	2025-09-26	Warnings	Exact identifier application number: M012
No Drip Severe Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5	2025-09-26	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa0b3be-2124-ed1d-e063-6294a90aaf48	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Medical Group Care LLC	3fa17255-514f-db47-e063-6294a90ae454	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa17272-fd7f-9ab4-e063-6394a90a585f	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa2e438-2ff3-a2df-e063-6394a90ac7b5	2025-09-25	Warnings	Exact identifier application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANT	GUAIFENESIN	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	63dad603-fe2f-42a6-a626-5c8048a42c10	2025-09-25	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa5220f-38bb-9ef6-e063-6294a90aeff8	2025-09-25	Warnings	Exact identifier application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Health Pharma USA LLC	a03befb4-d86d-43e4-8097-eda5c8bb25be	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f8d7d47-f14c-888c-e063-6394a90a5cdd	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3f909bc2-eb84-a19d-e063-6294a90ae04e	2025-09-24	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