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		2026-10-27

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 169 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERAFLU POWERPODS NIGHTTIME SEVERE COLD	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	39f9feef-4bf2-4f10-9fff-22bbb1d8a471	2024-01-30	Warnings	Exact identifier application number: M012
Theraflu Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	c0689223-5c90-4dbc-bbfa-f94e267504c3	2024-01-28	Warnings	Exact identifier application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	a4c56ca0-7785-404b-996d-137cc135f270	2024-01-28	Warnings	Exact identifier application number: M012
THERAFLU NIGHTTIME SEVERE COLD AND COUGH	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	5f7f6f70-0f36-4541-89f2-d953259cdb1e	2024-01-28	Warnings	Exact identifier application number: M012
RESFRIOL D	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	0e9c96b9-41ac-0faf-e063-6294a90a8ab5	2024-01-26	Warnings	Exact identifier application number: M012
Allergy Relief	ALLERGY RELIEF	Good Sense	bb709377-7bb3-4931-a2b6-2443aee07c12	2024-01-26	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	2024-01-23	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Honey Lemon	MENTHOL	Cardinal Health 110, Inc.	fe90dc33-2815-8296-e053-6294a90ac1df	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Cardinal Health 110, Inc.	fe91543e-a798-6399-e053-6394a90af5e5	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Black Cherry	MENTHOL	Cardinal Health 110, Inc.	fe90cf63-d286-fa5e-e053-6394a90a7759	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol Honey Lemon	COUGH DROPS MENTHOL	Cardinal Health 110, Inc.	fe5b3f6d-2a2d-f322-e053-6394a90aba04	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol	MENTHOL COUGH DROPS	Cardinal Health 110, Inc.	fe5b557e-a689-a32c-e053-6294a90aadbd	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Cherry	CHERRY FLAVOR COUGH DROPS	Cardinal Health 110, Inc.	fe5b5e57-1368-c62b-e053-6294a90ae82c	2024-01-19	Warnings	Exact identifier application number: M012
Leader Zinc Oxide	ZINC OXIDE	Cardinal Health 110,Inc.	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	2024-01-18	Warnings	Exact identifier application number: M012
Cough and Congestion DM Sugar Free	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	4656e60e-4733-45c1-bf55-d156e45085c6	2024-01-17	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Rugby Laboratories	775f97c0-6f82-49a8-82ac-f1a73920c3ec	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin Plus NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals, Inc.	99afe6a6-1350-49c6-9347-b7e531e35925	2024-01-11	Warnings	Exact identifier application number: M012
Childrens Tukol Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	85fe6f0f-41c8-44d3-a34a-355938da5f72	2024-01-11	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	ad437177-08eb-4811-883f-ac543d5bc58c	2024-01-11	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