FDA.reportPublic FDA data

Tussin DMMax

Product NDC
69618-072
11-digit product format
696180072
Labeler code
69618
Product ID
69618-072_47fd1379-0cd5-9b54-e063-6394a90a3948
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
RELIABLE 1 LABORATORIES LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
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
Tussin DMMax
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-072-582026-01-09C16284748780-12cef2736-ad1a-d83d-e063-dadaa90ab31fReliable Tussin DMMax 072
69618-072-582026-01-09C16284748780-12cef2736-ad1a-d83d-e063-dadaa90ab31fc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa
69618-072-582025-01-30C16284748780-12cef2736-ad1a-d83d-e063-dadaa90ab31fReliable Tussin DMMax 072
69618-072-582025-01-30C16284748780-12cef2736-ad1a-d83d-e063-dadaa90ab31fc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-072-58Tussin DMMax237 mL in 1 BOTTLELIQUID2374
69618-072-58Tussin DMMax1 in 1 CARTONLIQUID14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-072-58ML - Milliliter69618-072d0861b1b-d68a-4692-8b58-656623c9829912023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-072TUSSIN DMMAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [RELIABLE 1 LABORATORIES LLC]1Current NDC, Legacy NDC, 2 package rows20221230_c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-072-58696180072581 BOTTLE in 1 CARTON (69618-072-58) / 237 mL in 1 BOTTLE1 bottle2022-12-010000-00-00NoNoCurrent