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 164 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	62f7fcb9-e31a-4634-b1c2-44a9567e3a61	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Caplets	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	8e22f6bc-33ce-4bb0-99be-7947aa21f60e	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Syrup	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	777d2ac7-e3cc-4513-8b6f-b90b2ff2c672	2024-03-07	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS Pharmacy	4c6025ff-4982-4408-b077-75dd5f5b65b2	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	423fd5e6-5d90-4539-81e0-0ae23881ee3a	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	917df706-1982-4240-9f56-42d426b76cc5	2024-03-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	21a29998-29d6-4a36-a370-291d23bfb197	2024-03-05	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	3c7ef3cf-f7f9-42bc-bf20-e36954b9671f	2024-03-05	Warnings	Exact identifier application number: M012
QUALITY CHOICE NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	da06e994-6848-4c1e-9432-31de5e626ea4	2024-03-02	Warnings	Exact identifier application number: M012
QUALITY CHOICE DayTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	417c4fa9-6458-40d0-b22a-2415194e250f	2024-03-02	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Aurohealth LLC	8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2	2024-03-01	Warnings	Exact identifier application number: M012
APRODINE	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	A-S Medication Solutions	bbc268b8-fa66-4dc5-b935-f77ae39d28c8	2024-02-29	Warnings	Exact identifier application number: M012
XtraCare Vaporizing Chest Rub	CAMPHOR, MENTHOL	Rejoice International	c3e220d6-fff4-452f-99a9-bd701fc608a0	2024-02-28	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	ebbb2f4b-ba84-40ad-96f6-60225119a33b	2024-02-27	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	1c93c45d-1141-4599-83ba-6d3b38f9ffc4	2024-02-23	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	3dc293c9-736b-4bd8-b993-ff83b9909bcd	2024-02-23	Warnings	Exact identifier application number: M012
Childrens Dibromm Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health (Leader) 70000	10cc7d67-30c4-4451-bf74-78abae3c8e25	2024-02-23	Warnings	Exact identifier application number: M012
Nasal Spray, 24-7 for Life	OXYMETAZOLINE HYDROCHLORIDE 0.05%	Lil' Drug Store Products, Inc.	11d27c75-fd95-f9da-e063-6394a90ac6b0	2024-02-20	Warnings	Exact identifier application number: M012
Nighttime Cold and Cough childrens	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	11652e8a-2242-4449-8a41-a8e75509025e	2024-02-20	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