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 147 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dcf6cf-373c-ea83-e053-2a95a90ae57a	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5918-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5916-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
ALLERGY MULTISYMPTOM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e9ab8e-2252-180d-e053-2a95a90a788f	2024-10-17	Warnings	Exact identifier application number: M012
COLD PLUS HEAD CONGESTION SEVERE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	3430c7e4-e142-407e-bed5-358dd6bd10f7	2024-10-17	Warnings	Exact identifier application number: M012
COLD MAX	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a1aba467-c91f-4812-b0b9-ff5fdfa298e3	2024-10-17	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dd12f1-dd63-27ae-e053-2995a90aaaeb	2024-10-17	Warnings	Exact identifier application number: M012
COLD and FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e44ac549-3e9b-4271-a2b2-ecb124f79832	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	f171a389-8b22-429c-86bc-272156fdc1b7	2024-10-17	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	6c5b5427-e47a-4eff-928a-c891452facf9	2024-10-17	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	ddeb8978-84b6-4a19-b25e-99d1c29e58d9	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20baef9-6e68-6679-e053-2a95a90a2b63	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20b71fb-8787-c871-e053-2a95a90a8eb4	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20bc492-fed3-bf05-e053-2a95a90ad393	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	a4d6ecb9-ea67-41ed-917b-9bb4d1e50551	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	08fda81a-bedd-4ff3-9c32-2066d2cea3f9	2024-10-17	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	American Health Packaging	2fd702ea-3069-472c-b99e-c527f1375705	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Selder, S.A. de C.V.	c2b49d10-b60f-3072-e053-2a95a90af004	2024-10-17	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	1db914d3-8bba-405e-9bf9-9b1a5806284c	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	e2c35fae-9dd6-51f2-e053-2995a90a1e9e	2024-10-17	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