FDA.reportPublic FDA data

Childrens HoneyWorks Plus Nighttime Cough Syrup

Product NDC
68163-661
11-digit product format
681630661
Labeler code
68163
Product ID
68163-661_411be621-e3e7-2a14-e063-6394a90a90cf
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hbr, doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
RARITAN PHARMACEUTICALS INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
15; 6.25 mg/10mL; mg/10mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
Childrens HoneyWorks Plus Nighttime Cough Syrup
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/10mL
DOXYLAMINE SUCCINATE6.25 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, V9BI9B5YI2
Rxcui1115329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
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
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-661-04Childrens HoneyWorks Plus Nighttime Cough Syrup1 in 1 CARTONSOLUTION13
68163-661-04Childrens HoneyWorks Plus Nighttime Cough Syrup118 mL in 1 BOTTLESOLUTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-661CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [RARITAN PHARMACEUTICALS INC]2Current NDC, 2 package rows20241211_43230b3b-2984-4924-b46d-dc73a8194d23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN43230b3b-2984-4924-b46d-dc73a8194d233
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD43230b3b-2984-4924-b46d-dc73a8194d233
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY43230b3b-2984-4924-b46d-dc73a8194d233
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY43230b3b-2984-4924-b46d-dc73a8194d233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68163-661-04681630661041 BOTTLE in 1 CARTON (68163-661-04) / 118 mL in 1 BOTTLE1 bottle2023-02-01NoNoHistorical