FDA.reportPublic FDA data

RoboCough

Product NDC
71598-102
Requested package NDC
71598-102-40
11-digit product format
715980102
Labeler code
71598
Product ID
71598-102_2b5aa9c1-8e0b-09ec-e063-6394a90a699d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
DXM Pharmacuetical, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/3mL
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
2026-12-31
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
RoboCough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/3mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2002003Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32fa7a09-8624-44c1-b9e4-8a8f0594292bAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71598-102-40RoboCough120 mL in 1 BOTTLELIQUID1201
71598-102-40RoboCough1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71598-102ROBOCOUGH (DEXTROMETHORPHAN HBR) LIQUID [DXM PHARMACUETICAL, INC.]1Current NDC, 2 package rows20250112_32fa7a09-8624-44c1-b9e4-8a8f0594292b.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 1 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
application number: M010
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
application number: M010
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
application number: M010
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsExact identifier
application number: M010
Wal Som Nighttime Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreens4cb0f9ab-1be1-4b41-a233-bbd0327036e22026-08-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsExact identifier
application number: M010
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsExact identifier
application number: M010
CVS Nighttime Childrens Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACYd66b1a2e-49b6-473b-acec-2694c73ce8b42026-08-19WarningsExact identifier
application number: M010
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
application number: M010
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsExact identifier
application number: M010
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
application number: M010
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsExact identifier
application number: M010
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
application number: M010
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002003dextromethorphan HBr 30 MG in 3 mL Oral SolutionPSN32fa7a09-8624-44c1-b9e4-8a8f0594292b1
2002003dextromethorphan hydrobromide 10 MG/ML Oral SolutionSCD32fa7a09-8624-44c1-b9e4-8a8f0594292b1
2002003dextromethorphan HBr 30 MG per 3 ML Oral SolutionSY32fa7a09-8624-44c1-b9e4-8a8f0594292b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71598-102-40715980102401 BOTTLE in 1 CARTON (71598-102-40) / 120 mL in 1 BOTTLE1 bottle2023-10-01NoNoCurrent