Home NDC 52083-623-01 Tusslin
Product NDC 52083-623
Requested package NDC 52083-623-01
11-digit product format 520830623
Labeler code 52083
Product ID 52083-623_a5539e41-632f-4d48-8a49-1d93e5c531be
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Kramer Novis
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-01-27
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 8 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52083-623-01 TusslinPediatric 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-623 TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS] 3 Legacy NDC, 1 package rows 20190919_6fe91407-08c1-465b-9c00-251c94b1f7f0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52083-623-01 52083062301 30 mL in 1 BOTTLE, DROPPER (52083-623-01) 30 ml 2014-01-27 0000-00-00 No No Current