FDA.reportPublic FDA data

Dologen

Product NDC
52083-481
Requested package NDC
52083-481-02
11-digit product format
520830481
Labeler code
52083
Product ID
52083-481_ddc31276-446c-42f4-9558-04c7c6bff944
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate, Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Kramer Novis
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-11
Marketing end
0000-00-00
Substance
DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN
Active strength
2 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52083-48152083-481-02IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-481-022023-01-30C16284748780-1f386c64a-0c67-0266-e053-dadaa90a7c1aDologen
52083-481-902023-01-30C16284748780-1f386c64a-0c67-0266-e053-dadaa90a7c1aDologen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-481-02Dologen2 in 1 PACKETTABLET24
52083-481-90Dologen90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-481-90EA - Each52083-481635fb43c-f052-4ab9-942f-f24193c5686212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BSDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RPDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-481DOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]4Legacy NDC, 2 package rows20181231_f8490040-51cd-4825-aea7-09a618437d29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190931acetaminophen 650 MG / dexbrompheniramine maleate 2 MG Oral TabletPSNf8490040-51cd-4825-aea7-09a618437d294
1190931acetaminophen 650 MG / dexbrompheniramine maleate 2 MG Oral TabletSCDf8490040-51cd-4825-aea7-09a618437d294
1190931APAP 650 MG / Dexbrompheniramine maleate 2 MG Oral TabletSYf8490040-51cd-4825-aea7-09a618437d294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-481-02520830481022 TABLET in 1 PACKET (52083-481-02) 2 tablet2011-10-110000-00-00NoNoCurrent