Home NDC 80489-953 Drs pharmacy HEMORRHOIDAL
Product NDC 80489-953
11-digit product format 804890953
Labeler code 80489
Product ID 80489-953_563698a1-f78d-c496-e063-6294a90a6fe4
Type HUMAN OTC DRUG
Nonproprietary name phenylephrine HCL, witch hazel
Dosage form OINTMENT
Route TOPICAL
Labeler OL PHARMA TECH, LLC Drs PHARMACY
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-11-01
Substance PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL
Active strength 749; 2.5; 140 mg/g; mg/g; mg/g
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 24 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 80489-953-01 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 80489-953-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 80489-953-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 80489-953-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 80489-953-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 80489-953-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 80489-953-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 80489-953-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80489-953-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 80489-953-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 80489-953-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 80489-953-01 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Drs pharmacy HEMORRHOIDAL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 749 mg/g PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g MINERAL OIL 140 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup 04JA59TNSJ Internal UNII lookup T5L8T28FGP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1372298 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 2 of 23 · 441 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Numb520Spray LIDOCAINE, PHENYLEPHRINE HCL Ebanel Laboratories, Inc. 350f0e25-fbdc-c0c0-e063-6294a90a50a0 2026-08-20 Warnings Exact identifier application number: M015 Gembooxt Topical Numbing Cream LIDOCAINE Guangdong Quadrant Ecological Technology Co., Ltd. 49951a3e-3b62-3d66-e063-6294a90a9360 2026-08-12 Warnings Exact identifier application number: M015 NumbMD Lidocaine Cream Anorectal(hemorrhoidal) LIDOCAINE 5% EveryMarket Inc 52379055-d017-4d98-e063-6294a90a196c 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 52369a41-820d-cd7a-e063-6394a90ac6d1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 51d370b4-1c34-d203-e063-6394a90a80b1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD 5% Lidocaine cream LIDOCAINE 5% EveryMarket Inc 507d0c2c-9517-40f8-e063-6394a90a1996 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal) LIDOCAINE CREAM ANORECTAL EveryMarket Inc 483d81a3-7493-3391-e063-6394a90a2e3d 2026-08-12 Warnings Exact identifier application number: M015 Numbing Cream LIDOCAINE 100 KARMA INC 35b5ba9d-da1d-55d6-e063-6294a90a5fa8 2026-08-12 Warnings Exact identifier application number: M015 Treatonic hemorrhoid treatment 5% LIDOCAINE 100 KARMA INC 41442fa7-c511-07ca-e063-6294a90a3992 2026-08-12 Warnings Exact identifier application number: M015 Lidocaine numbing cream 5% LIDOCAINE 100 KARMA INC 47380721-6633-4a50-e063-6394a90aca94 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 47dc7630-9a74-1989-e063-6294a90a50bb 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 49e6b69f-bd6e-b415-e063-6394a90a8e65 2026-08-12 Warnings Exact identifier application number: M015 Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing LIDOCAINE Putian Licheng District Zhijiancheng Trading Co., Ltd. 4a7be9eb-5e57-90e8-e063-6394a90aad9e 2026-08-08 Warnings Exact identifier application number: M015 THE SOLU TION LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE SCALP TECH INC 58793581-8826-9a74-e063-6294a90a2465 2026-08-06 Warnings Exact identifier application number: M015 Lidocaine Numbing Cream LIDOCAINE Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 5457b3d7-e6b6-34a7-e063-6394a90aa240 2026-08-03 Warnings Exact identifier application number: M015 HEMORRHOIDALCREAMPROCURE PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL TWIN MED, LLC e9c44756-1c98-41be-e053-2995a90a35b4 2026-08-03 Warnings Exact identifier application number: M015 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE YYBA CORP 582a0001-da1e-909a-e063-6394a90a2b11 2026-08-03 Warnings Exact identifier application number: M015 up and up PHENYLEPHRINE HYDROCHLORIDE Target Corporation b42775ae-44fe-487e-b9ca-21d9687020a9 2026-07-29 Warnings Exact identifier application number: M015 Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 578fa642-ff30-e511-e063-6294a90a5987 2026-07-26 Warnings Exact identifier application number: M015 CVS Topical Anesthetic Hemorrhoidal DIBUCAINE CVS PHARMACY, INC 9f3d4fdb-ad82-4ab8-8a9e-252d027068ab 2026-07-25 Warnings Exact identifier application number: M015
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80489-953-01 80489095301 1 TUBE in 1 CARTON (80489-953-01) / 28.3 g in 1 TUBE 1 tube 2021-11-01 No No Current