FDA.reportPublic FDA data

M-END

Product NDC
12830-816
11-digit product format
128300816
Labeler code
12830
Product ID
12830-816_413d30e9-616e-f896-e063-6394a90acebc
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
R. A. McNeil Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-10-13
Substance
DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
.667; 10; 20 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], 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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage12830-816-161332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage12830-816-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage12830-816-16fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage12830-816-30fb8cb913e6d1…eb8c232b6be0…

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
M-END
Brand name suffix
DMX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXBROMPHENIRAMINE MALEATE.667 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE20 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BPA9UT29BSInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee1fae2e-3a21-4487-9989-c7620a4a7056Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
12830-816-162024-03-19M-END DMX
12830-816-162024-03-19M-END DMX
12830-816-302024-03-19M-END DMX
12830-816-302024-03-19M-END DMX
12830-816-162024-01-30M-END DMX
12830-816-162024-01-30M-END DMX
12830-816-302024-01-30M-END DMX
12830-816-302024-01-30M-END DMX
12830-816-162022-12-22M-END DMX
12830-816-162022-12-22M-END DMX
12830-816-302022-12-22M-END DMX
12830-816-302022-12-22M-END DMX
12830-816-162022-07-29M-END DMX
12830-816-162022-07-29M-END DMX
12830-816-302022-07-29M-END DMX
12830-816-302022-07-29M-END DMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12830-816-16M-ENDDMX473 mL in 1 BOTTLELIQUID4739
12830-816-30M-ENDDMX30 mL in 1 BOTTLELIQUID309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12830-816-16ML - Milliliter12830-8167caf2d65-b241-4862-9fda-e1c89f90c2c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dexbrompheniramine MaleateACTIVE INGREDIENTBPA9UT29BSM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
DexbrompheniramineACTIVE MOIETY75T64B71RPM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
DextromethorphanACTIVE MOIETY7355X3ROTSM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
PseudoephedrineACTIVE MOIETY7CUC9DDI9FM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
SorbitolINACTIVE INGREDIENT506T60A25RM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2
WaterINACTIVE INGREDIENT059QF0KO0RM-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12830-816M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]8Current NDC, Legacy NDC, 2 package rows20240321_ee1fae2e-3a21-4487-9989-c7620a4a7056.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 28 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Mucus Cough and Congestion ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8b5d391b-6c23-44c3-81d0-c08822bf6d012026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom ColdACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCe048cd53-a3cd-484f-a972-4cb49791dba32026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens CoughDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCb8132c81-5291-431a-ad3a-ec8a3eb21c192026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7354f57c-0ecf-481f-9482-0040c90c43502026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC5bda415d-739f-4ca5-b5b2-07c14a81863b2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8f3eb5c5-832e-4806-b3da-ef112cf55dcf2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDEReckitt Benckiser LLCe3aea6df-37a4-43c5-a192-a902cbff3f922026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd9e5a8d7-814c-4ab1-bb05-e4cb9155978e2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple PackACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINReckitt Benckiser LLCc7ab5201-8550-4bf4-957c-c8f049aeaa4a2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC84e7be8f-2785-45ef-9c44-de05394fcd992026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC771d7fd8-184f-48a3-90ed-e8f00159d97e2026-05-18WarningsExact identifier
application number: M012
MUCINEX Childrens Stuffy NoseOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLCde1c0abd-1644-4351-8106-e9df6ca5c1422026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Fever Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1538a75d-582a-9501-e063-6394a90a6c552026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC19105007-0193-0764-e063-6294a90a01a42026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC34fd2458-9acd-cdf7-e063-6394a90a3d0a2026-05-18WarningsExact identifier
application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3a24b06c-00a6-c2ef-e063-6294a90a4d722026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC14be3ab0-d6ae-e342-e063-6294a90ab8512026-05-18WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLBryant Ranch Prepack20f00537-2c8a-45d1-8e5f-ec276d0a47b62026-05-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.38df2308-f6f9-4476-ad34-4b5bc5f9fdf22026-05-18WarningsExact identifier
application number: M012
Allergy Plus Headache ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.88e3b969-79d0-4e64-95c0-c5cfd41e365f2026-05-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190600dexbrompheniramine maleate 0.667 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 20 MG in 5 mL Oral SolutionPSNee1fae2e-3a21-4487-9989-c7620a4a70569
1190600dexbrompheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 4 MG/ML Oral SolutionSCDee1fae2e-3a21-4487-9989-c7620a4a70569
1190600dexbrompheniramine maleate 0.667 MG / dextromethorphan hydrobromide 10 MG / pseudoephedrine hydrochloride 20 MG per 5 ML Oral SolutionSYee1fae2e-3a21-4487-9989-c7620a4a70569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12830-816-1612830081616473 mL in 1 BOTTLE (12830-816-16) 473 ml2011-10-130000-00-00NoNoCurrent
12830-816-301283008163030 mL in 1 BOTTLE (12830-816-30) 30 ml2011-10-130000-00-00NoNoCurrent