Home NDC 53145-302-84 Toa Syrup Adult
Product NDC 53145-302
Requested package NDC 53145-302-84
11-digit product format 531450302
Labeler code 53145
Product ID 53145-302_34d4e68b-8d1b-40e4-b076-21a4e525c7e9
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Menper Distributors, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-02-21
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 18 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 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 53145-302-84 Toa Syrup Adult 1 in 1 CARTON LIQUID 1 7 53145-302-84 Toa Syrup Adult 118 mL in 1 BOTTLE LIQUID 118 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 PHENYLEPHRINE ACTIVE INGREDIENT 1WS297W6MV TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 MENTHOL INACTIVE INGREDIENT L7T10EIP3A TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53145-302 TOA SYRUP ADULT (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MENPER DISTRIBUTORS, INC.] 7 Legacy NDC, 2 package rows 20210505_89cb36dd-f666-4d81-b276-3a653c8ac591.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 53145-302-84 53145030284 1 BOTTLE in 1 CARTON (53145-302-84) > 118 mL in 1 BOTTLE 1 bottle 2012-02-21 0000-00-00 No No Current