Home NDC 63868-208-12 Hemorrhoidal
Product NDC 63868-208
Requested package NDC 63868-208-12
11-digit product format 638680208
Labeler code 63868
Product ID 63868-208_c2b05115-160d-7c65-e053-2995a90a13fd
Type HUMAN OTC DRUG
Nonproprietary name COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Dosage form SUPPOSITORY
Route RECTAL
Labeler Chain Drug Marketing Association, Inc.
Application part346
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-09-26
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 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 63868-208-12 Hemorrhoidal 1 in 1 BLISTER PACK SUPPOSITORY 1 3 63868-208-12 Hemorrhoidal 12 in 1 BOX SUPPOSITORY 12 3 63868-208-24 Hemorrhoidal 1 in 1 BLISTER PACK SUPPOSITORY 1 3 63868-208-24 Hemorrhoidal 24 in 1 BOX SUPPOSITORY 24 3
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 [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1 COCOA BUTTER ACTIVE MOIETY 512OYT1CRR HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-208 HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.] 3 Legacy NDC, 4 package rows 20210520_a01ee29d-02ca-4473-aa90-c2e8174dba26.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-208-12 63868020812 12 BLISTER PACK in 1 BOX (63868-208-12) > 1 SUPPOSITORY in 1 BLISTER PACK 12 blister pack 2021-05-18 0000-00-00 No No Current