Home NDC 63868-483-18 Hemorroidal Cooling gel
Product NDC 63868-483
Requested package NDC 63868-483-18
11-digit product format 638680483
Labeler code 63868
Product ID 63868-483_bafe0e06-bc39-f23e-e053-2a95a90a7488
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine, Witch Hazel
Dosage form GEL
Route TOPICAL
Labeler Chain Drug Marketing Association
Application part346
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-07-15
Marketing end 0000-00-00
Substance WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1 g/100g; g/100g
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 · 9 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 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 63868-483-18 Hemorroidal Cooling gel 51 g in 1 TUBE GEL 51 3 63868-483-18 Hemorroidal Cooling gel 1 in 1 BOX GEL 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-483 HEMORROIDAL COOLING GEL (PHENYLEPHRINE, WITCH HAZEL) GEL [CHAIN DRUG MARKETING ASSOCIATION] 3 Legacy NDC, 2 package rows 20230525_8dbbb2c5-f89e-db7c-e053-2995a90a0572.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-483-18 63868048318 1 TUBE in 1 BOX (63868-483-18) > 51 g in 1 TUBE 1 tube 2019-07-15 0000-00-00 No No Current