Home NDC 52083-231 Tussi Pres
Product NDC 52083-231
11-digit product format 520830231
Labeler code 52083
Product ID 52083-231_15192bad-05a9-4d18-9604-db4122f47aad
Type HUMAN OTC DRUG
Nonproprietary name guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage form SYRUP
Route ORAL
Labeler Kramer Novis
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-03-28
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 40 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52083-231-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52083-231-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52083-231-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52083-231-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52083-231-16 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52083-231-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52083-231-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52083-231-16 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52083-231-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52083-231-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52083-231-16 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52083-231-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52083-231-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52083-231-16 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52083-231-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52083-231-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52083-231-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52083-231-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52083-231-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52083-231-16 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52083-231-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52083-231-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52083-231-16 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52083-231-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52083-231-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52083-231-16 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52083-231-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52083-231-04 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52083-231-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52083-231-04 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52083-231-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52083-231-04 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tussi Pres
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 200 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098647 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 52083-231-04 Tussi Pres 120 mL in 1 BOTTLE SYRUP 120 5 52083-231-10 Tussi Pres 10 mL in 1 PACKET SYRUP 10 5 52083-231-16 Tussi Pres 480 mL in 1 BOTTLE SYRUP 480 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-231 TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS] 4 Current NDC, Legacy NDC, 3 package rows 20221102_0d4ee530-2a5c-41a0-88bf-ac92d538661b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 132 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 Warnings Exact identifier application number: M012 Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 Warnings Exact identifier application number: M012
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 52083-231-04 52083023104 120 mL in 1 BOTTLE 120 ml Historical 52083-231-10 52083023110 10 mL in 1 PACKET (52083-231-10) 10 ml 2011-03-28 0000-00-00 No No Current 52083-231-16 52083023116 480 mL in 1 BOTTLE (52083-231-16) 480 ml 2011-03-28 0000-00-00 No No Current