TESALON Tesaperlas Severe Cold Max Relief

Product NDC
69729-788
11-digit product format
697290788
Labeler code
69729
Product ID
69729-788_4769d8b1-87ce-a188-e063-6294a90aa026
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
OPMX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-27
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/1; mg/1
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
TESALON Tesaperlas Severe Cold Max Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1661740

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-788-20TESALON Tesaperlas Severe Cold Max Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12
69729-788-20TESALON Tesaperlas Severe Cold Max Relief20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-788TESALON TESAPERLAS SEVERE COLD MAX RELIEF (DEXTROMETHORPHAN HBR, GUAIFENESIN) CAPSULE, LIQUID FILLED [OPMX LLC]1Current NDC, 2 package rows20241024_23223821-4fa0-5d99-e063-6394a90af0e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661740dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral CapsulePSN23223821-4fa0-5d99-e063-6394a90af0e52
1661740dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral CapsuleSCD23223821-4fa0-5d99-e063-6394a90af0e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-788-20697290788201 BLISTER PACK in 1 CARTON (69729-788-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2024-09-27NoNoHistorical