FDA.reportPublic FDA data

ACTINEL Diabetic

Product NDC
63102-140
11-digit product format
631020140
Labeler code
63102
Product ID
63102-140_f35e67f4-4a6e-4340-9b6d-60cdbf33b412
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
ACTIPHARMA, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-12
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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

Additional Listing Data#

Finished product
Yes
Brand name base
ACTINEL Diabetic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-140-16ACTINEL Diabetic473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN35c21623-84dd-4151-b35b-e7d30b69c9c01
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD35c21623-84dd-4151-b35b-e7d30b69c9c01
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY35c21623-84dd-4151-b35b-e7d30b69c9c01
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY35c21623-84dd-4151-b35b-e7d30b69c9c01
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY35c21623-84dd-4151-b35b-e7d30b69c9c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63102-140-1663102014016473 mL in 1 BOTTLE, PLASTIC (63102-140-16) 473 ml2026-02-12NoNoCurrent