CVS Health Non-Drowsy Nasal Decongestant

Product NDC
53240-240
11-digit product format
532400240
Labeler code
53240
Product ID
53240-240_cd2652b3-0228-4510-b7e1-f6b175914b78
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
PILL
Route
ORAL
Labeler
Westport Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-05
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53240-240IInactivated by FDA2026-10-12
excluded packagepackage53240-24053240-240-01IInactivated by FDA2026-10-12

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53240-240-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53240-240-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53240-240-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53240-240-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53240-240-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53240-240-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53240-240-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53240-240-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53240-240-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53240-240-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53240-240-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53240-240-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53240-240-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53240-240-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53240-240-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53240-240-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53240-240-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53240-240-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53240-240-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53240-240-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53240-240-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53240-240-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53240-240-012020-01-31C16284748780-19d75b9cf-f6ef-f424-e053-dadaa90a57cec4104df9-2f42-45ed-bf26-112ec418cd6b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53240-240-01CVS Health Non-Drowsy Nasal Decongestant48 in 1 PACKAGEPILL481

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
GUAR GUMINACTIVE INGREDIENTE89I1637KECVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RCVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53240-240CVS HEALTH NON-DROWSY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) PILL [WESTPORT PHARMACEUTICALS]1Legacy NDC, 1 package rows20151006_c4104df9-2f42-45ed-bf26-112ec418cd6b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53240-240-015324002400148 in 1 PACKAGEHistorical