RoboTablets

Product NDC: 71598-015
11-digit product format: 715980015
Labeler code: 71598
Product ID: 71598-015_5d31cc3f-3a14-d2e9-e063-6294a90af7bb
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan
Dosage form: TABLET
Route: ORAL
Labeler: DXM Pharmaceutical, Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-10-15
Substance: DEXTROMETHORPHAN
Active strength: 30 mg/1
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: RoboTablets
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7355X3ROTS	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b92cf698-032d-4d8d-b19c-456c6338b094	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71598-015-30	RoboTablets	100 in 1 BOTTLE, PLASTIC	TABLET	100		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71598-015	ROBOTABLETS (DEXTROMETHORPHAN) TABLET [DXM PHARMACEUTICAL, INC]	7	Current NDC, Legacy NDC, 1 package rows	20241009_b92cf698-032d-4d8d-b19c-456c6338b094.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 174 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a58bfb14-28f9-4425-a5a5-aaff4847c979	2018-03-14	Warnings	Exact identifier application number: M012
Chlorpheniramine maleate 4mg	CHLORPHENIRAMINE MALEATE 4MG	Athlete's Needs, Inc.	4d974959-25fc-4707-9b72-9afbf47b76f1	2017-11-14	Warnings	Exact identifier application number: M012
Cold Medicine	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Selder, S.A. de C.V.	d2762d9c-e7e7-42b2-a26a-14b2aa0307cb	2017-01-25	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Marc Glassman, Inc.	2051247f-ce64-4cf5-b449-9ca14c43ab86	2016-12-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7355X3ROTS	DEXTROMETHORPHAN	125-71-3	DEXTROMETHORPHAN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71598-015-30	71598001530	100 TABLET in 1 BOTTLE, PLASTIC (71598-015-30)	100 tablet	2020-10-15	0000-00-00	No	No	Current