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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage29978-127-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage29978-127-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage29978-127-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage29978-127-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage29978-127-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage29978-127-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage29978-127-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage29978-127-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage29978-127-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage29978-127-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage29978-127-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage29978-127-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage29978-127-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage29978-127-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage29978-127-15ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage29978-127-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage29978-127-15367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage29978-127-16367a005e9d99…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
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/5mL
PYRILAMINE MALEATE7.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1423307Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf778c5f-475e-4a86-a87c-2be1e665f5a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29978-127-15Capron DM15 mL in 1 BOTTLELIQUID159
29978-127-15Capron DM6 in 1 BOXLIQUID69
29978-127-16Capron DM473 mL in 1 BOTTLELIQUID4739
29978-127-16Capron DM1 in 1 BOXLIQUID19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29978-127-16ML - Milliliter29978-12796211107-5c26-4760-b878-5761d2631c6912013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZACAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PYRILAMINEACTIVE MOIETYHPE317O9TLCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29978-127CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]8Current NDC, Legacy NDC, 4 package rows20230111_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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationaa7164a7-f842-457d-abee-0740bb8c1c902026-08-19WarningsExact identifier
application number: M012
CVSCHILDRENS STUFFY NOSE AND COLDCVS PHARMACY, INC6cff265d-94a3-4617-a366-fe970d97f05a2026-08-19WarningsExact identifier
application number: M012
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
application number: M012
CVS Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCVS PHARMACY0ae0c244-e019-4b35-890c-8e15e3d3f7ce2026-08-19WarningsExact identifier
application number: M012
CVS Severe Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACYe32881f5-2bb5-4756-aa86-a09473ab590b2026-08-19WarningsExact identifier
application number: M012
Good Sense Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINL. Perrigo Companyd2541ef0-a73c-43aa-91ff-fdbce2748c4f2026-08-18WarningsExact identifier
application number: M012
CVS Severe Nasal Congestion Relief Clear and CoolOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.5a7e42ee-810c-4bc1-9d8d-fac8e849e1262026-08-18WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC8dd039b4-209a-484a-b15e-741d55087a932026-08-18WarningsExact identifier
application number: M012
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
application number: M012
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsExact identifier
application number: M012
Polytussin DMDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATEPoly Pharmaceuticals, Inc.fda8f594-82bf-1781-e053-6294a90ad3442026-08-18WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCda1f1ef9-a974-4998-8e1d-c1d9995969432026-08-18WarningsExact identifier
application number: M012
CVS Health Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.89168715-71b1-424e-8dae-fcfa90bc85bf2026-08-18WarningsExact identifier
application number: M012
CVS Health SinusOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.c7840511-3a4f-4547-ae90-19b085a5874e2026-08-17WarningsExact identifier
application number: M012
CVS HealthNASAL OXYMETAZOLINE HCLCVS Pharmacy,Inc.56f08e70-bf16-4933-97bc-177bc190d12a2026-08-17WarningsExact identifier
application number: M012
CVS Health No DripALLERGY NASALCVS PHARMACY,INC.3e76ffac-07a7-4b6a-bc4c-9cabb653e0642026-08-17WarningsExact identifier
application number: M012
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsExact identifier
application number: M012
CVS Overnight Cold and Flu Clear and CoolACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDECVS PHARMACY, INC2497a011-d7a0-4d69-97e2-bbf25a99b1cc2026-08-17WarningsExact identifier
application number: M012
Mucus Relief Cough Cold Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E B3ef949f5-ac8c-44be-b04d-6996fa59a94b2026-08-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1423307dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral SolutionPSNcf778c5f-475e-4a86-a87c-2be1e665f5a59
1423307dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral SolutionSCDcf778c5f-475e-4a86-a87c-2be1e665f5a59
1423307dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral SolutionSYcf778c5f-475e-4a86-a87c-2be1e665f5a59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29978-127-15299780127156 BOTTLE in 1 BOX (29978-127-15) / 15 mL in 1 BOTTLE6 bottle2013-06-200000-00-00NoNoCurrent
29978-127-16299780127161 BOTTLE in 1 BOX (29978-127-16) / 473 mL in 1 BOTTLE1 bottle2013-06-200000-00-00NoNoCurrent