Mielim y mas

Product NDC: 58593-295
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58593-295	58593-295-04	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090496	Internal RxNorm lookup
1099285	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
711d1dae-3af4-46af-a3a8-cd827356a81a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58593-295-04	2020-02-18	Drug Facts
58593-295-06	2020-02-18	Drug Facts
58593-295-04	2020-01-31	Drug Facts
58593-295-06	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-295-04	Mielim y mas	118 mL in 1 BOTTLE	LIQUID	118		8
58593-295-06	Mielim y mas	178 mL in 1 BOTTLE	LIQUID	178		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-295	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241016_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 61 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	c1fae6c7-bbac-1320-e053-2a95a90aac5a	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	f4c60ca1-ba59-4a92-84a5-6ba65faa56ab	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	cec51eab-cce3-4965-a14e-a46d953050c4	2026-01-08	Warnings	Exact identifier application number: M012
VanaCof 2	CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE	GM Pharmaceuticals, INC	0c7c6756-abb2-c10c-e063-6394a90a9863	2026-01-08	Warnings	Exact identifier application number: M012
VANACOF XP Cough / Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	GM Pharmaceuticals, INC	0b3a8cc1-a49f-e1e5-e063-6394a90a1c06	2026-01-08	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	INVAHEALTH INC	e4e4004f-77e3-569d-e053-2a95a90a73fe	2026-01-08	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	868ac65a-63e2-46ac-b87d-66b289086756	2026-01-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	0324195f-506d-4747-990e-ad44e2a117d9	2026-01-07	Warnings	Exact identifier application number: M012
Sambrosa Night	DOXYLAMINE SUCCINATE	Sambrosa Care, Inc.	acdc8740-6231-d1e8-e053-2995a90a3b8d	2026-01-07	Warnings	Exact identifier application number: M012
VAPOREX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	DLC Laboratories, Inc.	971943b1-4199-4f75-9d2d-61242d346b5f	2026-01-07	Warnings	Exact identifier application number: M012
BACTIMICINA COUGH AND COLD	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DLC Laboratories, Inc.	2e612c62-9bbb-45f2-a253-aa2bfaeaac70	2026-01-07	Warnings	Exact identifier application number: M012
Earths Care Chest Rub	CAMPHOR, EUCALYPTUS OI, MENTHOL	DLC Laboratories, Inc	2424f5d5-1772-96f1-e063-6294a90a89ee	2026-01-07	Warnings	Exact identifier application number: M012
Bactimicina Vapor Rub	VAPOR RUB	DLC Laboratories, Inc.	176b617a-faf6-7893-e063-6294a90a046b	2026-01-07	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain	ACETAMINOPHEN, PHENYLEPHRINE HCL	Family Dollar Services Inc	0d3e4ceb-5059-4aac-8aa2-bf714ca9deb2	2026-01-07	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	b225e897-5728-4519-b727-c0f361c75976	2026-01-07	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	80b218f7-66bb-4e15-a0dc-ec9b6af1b056	2026-01-07	Warnings	Exact identifier application number: M012
tussin cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	13618054-d0c5-4190-b626-e7e91b855738	2026-01-06	Warnings	Exact identifier application number: M012
Berkley and Jensen Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	c15b97a8-968f-4d38-905e-863e9fd16ce6	2026-01-06	Warnings	Exact identifier application number: M012
Complete Allergy Medicine	DIPHENHYDRAMINE HCL	Salado Sales, Inc.	c0f5c8ca-b187-40bf-9245-6a29f1c32c97	2026-01-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	c5776b1e-9f72-4a6a-9961-8ac8e05b3249	2026-01-06	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
7355X3ROTS	DEXTROMETHORPHAN	125-71-3	Dextromethorphan

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090496	dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	711d1dae-3af4-46af-a3a8-cd827356a81a	8
1099285	Mielim y mas 15 MG in 5 mL Oral Solution	PSN	711d1dae-3af4-46af-a3a8-cd827356a81a	8
1099285	dextromethorphan hydrobromide 3 MG/ML Oral Solution [Mielim Y Mas]	SBD	711d1dae-3af4-46af-a3a8-cd827356a81a	8
1090496	dextromethorphan hydrobromide 3 MG/ML Oral Solution	SCD	711d1dae-3af4-46af-a3a8-cd827356a81a	8
1090496	dextromethorphan hydrobromide 15 MG per 5 ML Oral Solution	SY	711d1dae-3af4-46af-a3a8-cd827356a81a	8
1090496	dextromethorphan hydrobromide 30 MG per 10 ML Oral Solution	SY	711d1dae-3af4-46af-a3a8-cd827356a81a	8
1099285	Mielim Y Mas 15 MG per 5 ML Oral Solution	SY	711d1dae-3af4-46af-a3a8-cd827356a81a	8
1099285	Mielim Y Mas 3 MG/ML Oral Solution	SY	711d1dae-3af4-46af-a3a8-cd827356a81a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58593-295-04	58593029504	118 mL in 1 BOTTLE (58593-295-04)	118 ml	1997-02-01	0000-00-00	No	No	Current
58593-295-06	58593029506	178 mL in 1 BOTTLE (58593-295-06)	178 ml	1997-02-01	0000-00-00	No	No	Current