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 101 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GoodSense Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	GOOD SENSE	240bb6af-9d38-49fe-9011-3016246b0986	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Honey Lemon Cough Drops	HONEY LEMON COUGH DROPS	Cintas Corporation	79e0b7c1-4acc-41d2-89cd-d075a8bac0c9	2025-09-23	Warnings	Exact identifier application number: M012
Topcare NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	b2b3c450-e988-41d1-9e53-cc8e30d75cb4	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Cherry Cough Drops	CHERRY COUGH DROPS	Cintas Corporation	d1fd2f23-5435-405d-a7fd-644691f79e80	2025-09-23	Warnings	Exact identifier application number: M012
Topcare DayTime NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	560fb22b-391f-4d7b-a6fd-38d577d404b0	2025-09-23	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f67ac3d-1503-3418-e063-6394a90a938f	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories Inc.	3f68e68a-cf32-9df8-e063-6394a90a3012	2025-09-22	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kramer Novis	f0bec5f5-4d76-471e-9024-557eba848b93	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	9f050fb0-6100-4b14-b82f-1d5fcbf16540	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	c6392ace-c7d1-4450-8b71-4dccc60b4f02	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f12ee8f-d1c6-d73a-e063-6394a90a9199	2025-09-18	Warnings	Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3d71d306-893a-e73a-e063-6394a90a0a3b	2025-09-18	Warnings	Exact identifier application number: M012
Giltuss D	GILTUSS D	Dextrum Laboratories Inc.	3f17eefb-b625-b0f2-e063-6294a90afd4d	2025-09-18	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b	2025-09-17	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories Inc	3effaf4b-28c3-6131-e063-6294a90a17ff	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	1872e1ff-2e08-c404-e063-6294a90afa14	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1323a67c-b9c5-038c-e063-6394a90a5e6b	2025-09-17	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f025ef6-79e7-e833-e063-6294a90ab501	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	186f8519-655d-bd21-e063-6294a90a16a8	2025-09-17	Warnings	Exact identifier application number: M012
AXIV NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	131f6314-c9a1-7af3-e063-6294a90abe6f	2025-09-17	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
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