FDA.reportPublic FDA data

Honey Works

Product NDC
68163-774
11-digit product format
681630774
Labeler code
68163
Product ID
68163-774_411bc223-b429-cc2d-e063-6394a90a51a2
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
SYRUP
Route
ORAL
Labeler
RARITAN PHARMACEUTICALS INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-20
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
20 mg/20mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Honey Works
Brand name suffix
Organic Honey
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1090946

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68163-774-042024-12-06C16284748780-11030e364-fb6e-111a-e063-dadaa90a10e2Honey Works™ Organic Honey Cough Syrup
68163-774-042024-12-06C16284748780-11030e364-fb6e-111a-e063-dadaa90a10e2Honey Works™ Organic Honey Cough Syrup
68163-774-042024-01-30C16284748780-11030e364-fb6e-111a-e063-dadaa90a10e2Honey Works™ Organic Honey Cough Syrup
68163-774-042024-01-30C16284748780-11030e364-fb6e-111a-e063-dadaa90a10e2Honey Works™ Organic Honey Cough Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-774-04Honey WorksOrganic Honey1 in 1 CARTONSYRUP16
68163-774-04Honey WorksOrganic Honey118 mL in 1 BOTTLESYRUP1186
68163-774-08Honey WorksOrganic Honey1 in 1 CARTONSYRUP16
68163-774-08Honey WorksOrganic Honey236 mL in 1 BOTTLESYRUP2366

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-774HONEY WORKS ORGANIC HONEY (DEXTROMETHORPHAN HBR) SYRUP [RARITAN PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 4 package rows20241208_178b5441-bf13-400c-8ab1-d05b3ceeb05b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090946dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN178b5441-bf13-400c-8ab1-d05b3ceeb05b6
1090946dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD178b5441-bf13-400c-8ab1-d05b3ceeb05b6
1090946dextromethorphan HBr 20 MG in 20 mL Oral SolutionSY178b5441-bf13-400c-8ab1-d05b3ceeb05b6
1090946dextromethorphan hydrobromide 5 MG per 5 ML Oral SolutionSY178b5441-bf13-400c-8ab1-d05b3ceeb05b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68163-774-04681630774041 BOTTLE in 1 CARTON (68163-774-04) / 118 mL in 1 BOTTLE1 bottle2019-05-200000-00-00NoNoCurrent
68163-774-08681630774081 BOTTLE in 1 CARTON (68163-774-08) / 236 mL in 1 BOTTLE1 bottle2019-05-20NoNoCurrent