Home NDC 68784-101-12 Hemorrhoidal
Product NDC 68784-101
Requested package NDC 68784-101-12
11-digit product format 687840101
Labeler code 68784
Product ID 68784-101_c1249e20-5c0f-d0a2-e053-2995a90a6073
Type HUMAN OTC DRUG
Nonproprietary name COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Dosage form SUPPOSITORY
Route RECTAL
Labeler Acino Products, LLC.
Application part346
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-04-29
Marketing end 0000-00-00
Substance COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1769 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68784-101 68784-101-12 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68784-101 68784-101-12 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68784-101 68784-101-12 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 COCOA BUTTER ACTIVE INGREDIENT 512OYT1CRR HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [ACINO PRODUCTS, LLC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [ACINO PRODUCTS, LLC.] 1 COCOA BUTTER ACTIVE MOIETY 512OYT1CRR HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [ACINO PRODUCTS, LLC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [ACINO PRODUCTS, LLC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [ACINO PRODUCTS, LLC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [ACINO PRODUCTS, LLC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [ACINO PRODUCTS, LLC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68784-101-12 68784010112 12 BLISTER PACK in 1 BOX (68784-101-12) > 1 SUPPOSITORY in 1 BLISTER PACK 12 blister pack 2021-04-29 0000-00-00 No No Current