Home NDC 46994-935 Acetaminophen
Product NDC 46994-935
11-digit product format 469940935
Labeler code 46994
Product ID 46994-935_f3009ddd-7853-42bf-a59c-588713204584
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler SAVE-A-LOT FOOD STORES, LTD.
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1994-05-15
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500 mg/1; mg/1
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 · 4 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 46994-935-15 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 46994-935-15 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46994-935 ACETAMINOPHEN EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 15 Legacy NDC 20240816_00dcd9d6-047a-45f3-a2d6-a3816e2c385f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46994-935-15 46994093515 1 BOTTLE in 1 CARTON (46994-935-15) > 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1994-05-15 0000-00-00 No No Current