FDA.reportPublic FDA data

Mielim y mas

Product NDC
58593-295
Requested package NDC
58593-295-06
11-digit product format
585930295
Labeler code
58593
Product ID
58593-295_24701771-2c31-2dfd-e063-6394a90a99db
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan
Dosage form
LIQUID
Route
ORAL
Labeler
Efficient Laboratories Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-02-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 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
2027-12-31
Current FDA listing
Yes

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
Mielim y mas
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090496Internal RxNorm lookup
1099285Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
711d1dae-3af4-46af-a3a8-cd827356a81aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58593-295-042020-02-18Drug Facts
58593-295-062020-02-18Drug Facts
58593-295-042020-01-31Drug Facts
58593-295-062020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-295-04Mielim y mas118 mL in 1 BOTTLELIQUID1188
58593-295-06Mielim y mas178 mL in 1 BOTTLELIQUID1788

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
HONEYINACTIVE INGREDIENTY9H1V576FHMIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-295MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]8Current NDC, Legacy NDC, 2 package rows20241016_711d1dae-3af4-46af-a3a8-cd827356a81a.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 6 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012
CVS Adult Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY822d5bf6-8841-4b7f-bbf7-90c3d50b80242026-08-19WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
application number: M012
Daytime and Nighttime Cough and Chest Congestion ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATECVS Pharmacy347f1731-5b85-4220-ae2b-9497a3afa4ed2026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
application number: M012
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
application number: M012
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories89752c69-25c8-45e3-9021-f81b35b52d362026-08-19WarningsExact identifier
application number: M012
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN711d1dae-3af4-46af-a3a8-cd827356a81a8
1099285Mielim y mas 15 MG in 5 mL Oral SolutionPSN711d1dae-3af4-46af-a3a8-cd827356a81a8
1099285dextromethorphan hydrobromide 3 MG/ML Oral Solution [Mielim Y Mas]SBD711d1dae-3af4-46af-a3a8-cd827356a81a8
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD711d1dae-3af4-46af-a3a8-cd827356a81a8
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY711d1dae-3af4-46af-a3a8-cd827356a81a8
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY711d1dae-3af4-46af-a3a8-cd827356a81a8
1099285Mielim Y Mas 15 MG per 5 ML Oral SolutionSY711d1dae-3af4-46af-a3a8-cd827356a81a8
1099285Mielim Y Mas 3 MG/ML Oral SolutionSY711d1dae-3af4-46af-a3a8-cd827356a81a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-295-0658593029506178 mL in 1 BOTTLE (58593-295-06) 178 ml1997-02-010000-00-00NoNoCurrent