Home NDC 46084-101 ACETAMINOPHEN SINUS CONGESTION AND PAIN
Product NDC 46084-101
11-digit product format 460840101
Labeler code 46084
Product ID 46084-101_529b0e8e-4f74-4d96-b9dc-c57ba66162d3
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler A P J Laboratories Limited
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-06-06
Marketing end 0000-00-00
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 46084-101-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 46084-101-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 46084-101-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 46084-101-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 46084-101-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 46084-101-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 46084-101-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 46084-101-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 46084-101-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 46084-101-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 46084-101-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 46084-101-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 46084-101-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 46084-101-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 46084-101-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 46084-101-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 46084-101-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 46084-101-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 46084-101-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 46084-101-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 46084-101-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 46084-101-30 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 46084-101-30 ACETAMINOPHEN SINUS CONGESTION AND PAINA P J COATED 30 in 1 BLISTER PACK TABLET 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 METHYLENE CHLORIDE INACTIVE INGREDIENT 588X2YUY0A ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 SALICYLIC ACID INACTIVE INGREDIENT O414PZ4LPZ ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46084-101 ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED] 4 Legacy NDC, 1 package rows 20130607_44a25c50-b16b-407c-99ea-668afca25924.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 46084-101-30 46084010130 30 in 1 BLISTER PACK Historical