Capron DM

Product NDC: 29978-127
11-digit product format: 299780127
Labeler code: 29978
Product ID: 29978-127_37da30a9-c2bd-ea24-e063-6294a90a6e8a
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr and Pyrilamine Maleate
Dosage form: LIQUID
Route: ORAL
Labeler: Capital Pharmaceutical, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-06-20
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Active strength: 7.5; 7.5 mg/5mL; mg/5mL
Pharmacologic classes: 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: 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 · 27 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
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	29978-127-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	29978-127-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	29978-127-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	29978-127-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	29978-127-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	29978-127-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	29978-127-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	29978-127-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	29978-127-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	29978-127-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	29978-127-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	29978-127-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	29978-127-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	29978-127-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	29978-127-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	29978-127-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	29978-127-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	29978-127-16	`367a005e9d99…`	`383a685ebd0f…`

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: Capron DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg/5mL
PYRILAMINE MALEATE	7.5 mg/5mL

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
R35D29L3ZA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1423307	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
cf778c5f-475e-4a86-a87c-2be1e665f5a5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
29978-127-15	2025-06-20	Capron DM Liquid
29978-127-16	2025-06-20	Capron DM Liquid
29978-127-15	2024-07-30	Capron DM Liquid
29978-127-16	2024-07-30	Capron DM Liquid
29978-127-15	2024-01-30	Capron DM Liquid
29978-127-16	2024-01-30	Capron DM Liquid
29978-127-15	2020-03-12	Capron DM Liquid
29978-127-16	2020-03-12	Capron DM Liquid
29978-127-15	2020-01-31	Capron DM Liquid
29978-127-16	2020-01-31	Capron DM Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29978-127-15	Capron DM	15 mL in 1 BOTTLE	LIQUID	15	9
29978-127-15	Capron DM	6 in 1 BOX	LIQUID	6	9
29978-127-16	Capron DM	473 mL in 1 BOTTLE	LIQUID	473	9
29978-127-16	Capron DM	1 in 1 BOX	LIQUID	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29978-127-16	ML - Milliliter	29978-127	96211107-5c26-4760-b878-5761d2631c69	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
PYRILAMINE MALEATE	ACTIVE INGREDIENT	R35D29L3ZA	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
PYRILAMINE	ACTIVE MOIETY	HPE317O9TL	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29978-127	CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]	8	Current NDC, Legacy NDC, 4 package rows	20230111_cf778c5f-475e-4a86-a87c-2be1e665f5a5.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 32 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	14c56f3d-67fd-45ef-a16b-f27604722883	2026-05-12	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare, LLC.	51a4195b-8776-964c-e063-6294a90aa075	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ba3548e-85e7-b4a6-e063-6394a90af84d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	fe7eeb71-e219-4c84-ac06-98c3a40b14dc	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	6f8241d7-0f30-40b3-926b-861c57079f1d	2026-05-12	Warnings	Exact identifier application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51a45db8-2bee-6fd0-e063-6394a90ab587	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	19da539e-7b57-41d7-aad5-fc89a6705e20	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	182222b5-a852-4dbe-b05f-a41d89806021	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8a790eeb-7d7d-4a94-9103-6ed09c04d596	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	dbdafbb4-f3c9-4042-b867-db4d06dc3d61	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	29571047-4c4b-44ca-8726-57c28308e8cf	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	75c6b92f-219f-4740-bb72-c02a927a21ff	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	c746953f-4b7d-4e2a-9b85-96bd6901f517	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	cea08797-1d53-4434-be1a-144f2ded5f9d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	2ef9d5de-e99e-4398-bf97-c7bef94498fa	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a401eb92-60b6-427d-a677-29371a3150be	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ff4c4ea-7628-4d2b-a6e9-d994c25baef4	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7c18e95-8d7b-4550-9a20-fc704a114adb	2026-05-12	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
R35D29L3ZA	PYRILAMINE MALEATE	59-33-6	PYRILAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1423307	dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral Solution	PSN	cf778c5f-475e-4a86-a87c-2be1e665f5a5	9
1423307	dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral Solution	SCD	cf778c5f-475e-4a86-a87c-2be1e665f5a5	9
1423307	dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral Solution	SY	cf778c5f-475e-4a86-a87c-2be1e665f5a5	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29978-127-15	29978012715	6 BOTTLE in 1 BOX (29978-127-15) / 15 mL in 1 BOTTLE	6 bottle	2013-06-20	0000-00-00	No	No	Current
29978-127-16	29978012716	1 BOTTLE in 1 BOX (29978-127-16) / 473 mL in 1 BOTTLE	1 bottle	2013-06-20	0000-00-00	No	No	Current