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 |
|---|---|---|---|---|---|---|
| Flarestop Hemorrhoid Lidocaine | LIDOCAINE | Chelsea Pharmacceuticals LLC | b8a589f7-7131-4807-9bcb-84af3078e258 | 2026-09-10 | Warnings | M015 |
| BCBCYC Numbing Cream | LIDOCAINE 5% NUMBING CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5ab36566-ba2f-06ef-e063-6394a90a71b5 | 2026-09-10 | Warnings | M015 |
| 5% Lidocaine 10g | 5% LIDOCAINE | Chongqing Mandongzi Technology Co., Ltd | 5b10530f-47cd-c4bd-e063-6294a90aaa0a | 2026-09-09 | Warnings | M015 |
| Hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | Rite Aid Corporation | 407c78ca-6fee-4ed6-b61b-711ec049c86e | 2026-09-09 | Warnings | M015 |
| Hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | CVS Pharmacy | 3167c918-a7d3-46a1-a85b-64f9c22916f2 | 2026-09-04 | Warnings | M015 |
| Flushable Hemorrhoidal Medicated Wipes Maximum Strength | WITCH HAZEL | Amazon.com Services LLC | 41d756f3-e523-ed14-e063-6394a90ab817 | 2026-09-03 | Warnings, Adverse reactions | M015 |
| Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel | HEMORRHOIDAL WIPES WITH WITCH HAZEL | Better Living Brands LLC | adf26111-70ba-596c-e053-2995a90ac6f1 | 2026-09-03 | Warnings, Adverse reactions | M015 |
| up and up medicated wipes manixim strength | GENTLE HEMORRHOIDAL CARE | Target Corporation | 271eab2b-ed13-39f1-e054-00144ff88e88 | 2026-09-03 | Warnings, Adverse reactions | M015 |
| KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE | WITCH HAZEL CLOTH | The Kroger Co. | 48c1598d-6667-446f-ac90-10ab945d0617 | 2026-09-03 | Warnings, Adverse reactions | M015 |
| Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel | WITCH HAZEL | Old East Main Co. | 2055289d-962e-46a9-b371-b5bb93dd46b4 | 2026-09-03 | Warnings, Adverse reactions | M015 |
| Equate Hemorrhoidal Medicated Wipes | WITCH HAZEL | Walmart Inc. | 8d57f054-77dc-4205-85f1-b65dcfde677b | 2026-09-03 | Warnings, Adverse reactions | M015 |
| Lidocaine Cream | LIDOCAINE | InvaDerm Corporation | 5a7273d1-1dbc-420e-e063-6294a90a8629 | 2026-09-01 | Warnings | M015 |
| Lidocaine Phenylephrine | LIDOCAINE PHENYLEPHRINE | YYBA CORP | 5a72a190-2129-411e-e063-6394a90a08c2 | 2026-09-01 | Warnings | M015 |
| INICEI 5% LIDOCAINE Numbing Cream | 5% LIDOCAINE NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5a65842f-27a1-268b-e063-6294a90a6054 | 2026-08-31 | Warnings | M015 |
| AnievaLC | LIDOCAINE | Blackstone Products, LLC | ddaba14c-10de-44e2-ae13-9217e20cb48e | 2026-08-29 | Warnings | M015 |
| Norms Hemorrhoid Wipes | WITCH HAZEL | Totally Normal Company | 5a1af50b-8d00-f589-e063-6394a90af86c | 2026-08-28 | Warnings | M015 |
| LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) Cream | LIDOCAINE | Guangzhou Hechuang Commercial Service Co.,Ltd. | 59f0fa16-5eb0-e6bb-e063-6294a90aacf5 | 2026-08-26 | Warnings | M015 |
| Dude Hemorrhoidal Wipes | WITCH HAZEL | Dude Products | fdf408ef-9392-a812-e053-6394a90a0017 | 2026-08-25 | Warnings | M015 |
| Norms Medicated Wipes | WITCH HAZEL | Totally Normal Company | 3a78e109-3f7c-fb19-e063-6394a90ae78e | 2026-08-22 | Warnings | M015 |
| Lidocaine Numbing Cream | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 599b425a-0e96-76df-e063-6394a90a48ff | 2026-08-21 | 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 |