Home NDC 51645-709-05 Plus Pharma Extra Strength Acetaminophen PM
Product NDC 51645-709
Requested package NDC 51645-709-05
11-digit product format 516450709
Labeler code 51645
Product ID 51645-709_994fb1ab-d6e7-610f-e053-2a95a90a25c3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen,Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gemini Pharmaceuticals, Inc. dba Plus Pharma
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2006-03-27
Marketing end 2021-06-30
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500 mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PLUS PHARMA EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51645-709-05 51645070905 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51645-709-05) 2006-03-27 2021-06-30 No No Current