Anorectal
- Product NDC
- 53329-088
- 11-digit product format
- 533290088
- Labeler code
- 53329
- Product ID
- 53329-088_efcefe93-0ec5-2aa1-e053-2995a90a8f22
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- zinc oxide, petrolatum
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M015
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2010-03-01
- Marketing end
- 0000-00-00
- Substance
- PETROLATUM; ZINC OXIDE
- Active strength
- 800 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53329-088 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 53329-088 | 53329-088-14 | D | Discontinued by firm | 2026-10-15 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-088-14 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-088-14 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-088-14 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-088-14 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-088-14 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-088-14 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-088-14 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-088-14 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-088-14 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-088-14 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-088-14 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-088-14 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 53329-088-14 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 53329-088-14 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 53329-088-14 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 53329-088-14 | 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.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53329-088-14 | 2022-10-04 | C162847 | 48780-1 | d6a99b39-b972-a426-e053-dadaa90af4c2 | 088 Curad Zinc Oxide Anorectal Cream |
| 53329-088-14 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b972-a426-e053-dadaa90af4c2 | 088 Curad Zinc Oxide Anorectal Cream |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PETROLATUM | ACTIVE INGREDIENT | 4T6H12BN9U | ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.] | 2 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.] | 2 | |
| PETROLATUM | ACTIVE MOIETY | 4T6H12BN9U | ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.] | 2 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.] | 2 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Moisture Barrier | MENTHOL 0.44%, ZINC OXIDE 20.6% | Walgreen Company | 258f3392-0f42-21e8-e063-6294a90ae9ad | 2026-07-22 | Warnings | M015 |
| Ma Ying Long Musk Hemorrhoids | PETROLATUM, ZINC OXIDE | Mayinglong Pharmaceutical Group Co., Ltd. | af466f21-c4bc-3b89-e053-2995a90a49f2 | 2026-07-20 | Warnings | M015 |
| RectaEase Hemorrhoid Relief Cream | LIDOCAINE | Trifecta Pharmaceuticals USA LLC | c054921a-9f1b-7c75-e053-2995a90a1738 | 2026-07-20 | Warnings | M015 |
| Lidocaine Numbing Cream | LIDOCAINE | KORVIA GLOBAL Inc. | 5690db03-4d62-9660-e063-6394a90a2fc0 | 2026-07-14 | Warnings | M015 |
| Zmztuhua Numbing Cream | LIDOCAINE | Guangzhou Hechuang Commercial Service Co.,Ltd. | 56417dc6-c14b-ad17-e063-6294a90af7e5 | 2026-07-10 | Warnings | M015 |
| Tina Davies IceCream | LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 6a2b3199-f405-4455-9a02-8885d24eef9c | 2026-07-09 | Warnings | M015 |
| Drs pharmacy HEMORRHOIDAL | PHENYLEPHRINE HCL, WITCH HAZEL | OL PHARMA TECH, LLC Drs PHARMACY | 164169b9-0627-9d1a-e063-6294a90ac46d | 2026-07-09 | Warnings | M015 |
| CAREALL Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | New World Imports, Inc | 561c601f-c2cd-f09c-e063-6294a90adb45 | 2026-07-08 | Warnings | M015 |
| Welmate Numbing Relief | LIDOCAINE 5% | YYBA Corp | 562162c0-7a85-f83c-e063-6294a90a8fc5 | 2026-07-08 | Warnings | M015 |
| Witch Hazel | WITCH HAZEL | H E B | 09b814f4-86b5-4810-bf52-cc88396451c2 | 2026-07-07 | Warnings, Adverse reactions | M015 |
| Witch Hazel | WITCH HAZEL | ADUSA Distribution, LLC | c50d0496-6f09-43c2-9383-3250885968c9 | 2026-06-29 | Warnings, Adverse reactions | M015 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Cream | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 55260a3e-637a-c53b-e063-6394a90a1b09 | 2026-06-27 | Warnings | M015 |
| Walgreens Hemorrhoidal | HEMORRHOIDAL RECTAL SUPPOSITORIES | Walgreens | 20c41406-99b2-bc89-e063-6294a90aed73 | 2026-06-25 | Warnings | M015 |
| CalaSoothe | CALAMINE, MENTHOL, AND ZINC OXIDE | Dynarex Corporation | 54f12005-acfe-4821-e063-6394a90ac304 | 2026-06-24 | Warnings | M015 |
| tina davies IceCream Hemorrhoidal | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd | 2026-06-24 | Warnings | M015 |
| Haemorrhoidal Pain Relief | ANORECTAL CREAM | NeilMed Pharmaceuticals Inc | 544a9d6f-4eaa-613e-e063-6294a90a0c50 | 2026-06-15 | Warnings | M015 |
| Dr.Seymour Butts Hemorrhoid | LIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 4981c7d9-53ee-2a7b-e063-6394a90add01 | 2026-06-12 | Warnings | M015 |
| ANIXIKE Numbing | LIDOCAINE4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d5b7c4c-feac-4eeb-e063-6294a90a5748 | 2026-06-11 | Warnings | M015 |
| tina davies IceJelly Hemorrhoidal | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 580559bf-d91f-4bb3-9c9b-b7e2cd0686fd | 2026-06-11 | Warnings | M015 |
| Equaline Hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | United Natural Foods, Inc. dba UNFI | bf87824a-522d-46da-81b6-e30ea11a2235 | 2026-06-11 | Warnings | M015 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-088-14 | 53329008814 | 1 TUBE in 1 BOX (53329-088-14) > 56.6 g in 1 TUBE | 1 tube | 2010-03-01 | 0000-00-00 | No | No | Current |