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 |
|---|---|---|---|---|---|---|
| CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots | LIDOCAINE | CVS PHARMACY, INC | caef51a8-76e9-42b3-a160-c54f62b47de1 | 2026-01-05 | Warnings | M015 |
| CVS Maximum OTC Strength Hemorrhoidal with Aloe | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM | CVS PHARMACY,INC | b55c63fb-5dfa-4567-8192-58f403868837 | 2026-01-02 | Warnings | M015 |
| HemRid Anorectal Cream | LIDOCAINE | KKA & Associates LLC | dbeb4325-3e85-1147-e053-2995a90a2160 | 2025-12-31 | Warnings | M015 |
| ElixirCurozole | CLOTRIMAZOLE | ELIXIR HEALTHCARE USA, LLC. | 0c468a9e-d092-4704-b742-92ecd9918209 | 2025-12-26 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | 5162baee-0d63-494e-8046-459437b85348 | 2025-12-25 | Warnings | M015 |
| HEMORRHOIDAL | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE | Safeway | 3e6728b6-26e3-4287-8ba6-e27f305cd93b | 2025-12-20 | Warnings | M015 |
| PREPARATION H | PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 40fde50a-3cc0-4286-9b33-8f3912254c33 | 2025-12-18 | Warnings | M015 |
| ElixirLidoFast Rapid Relief | GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE | ELIXIR HEALTHCARE USA, LLC. | 45de9dfa-6c89-1eae-e063-6294a90a4dac | 2025-12-13 | Warnings | M015 |
| topcare hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Topco Associates LLC | 81a3546b-5099-4b9a-b774-b3e79316b267 | 2025-12-13 | Warnings | M015 |
| Kroger Hemorrhoid | GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL | Kroger Company | 45b2dd86-7fb0-07bf-e063-6394a90a1884 | 2025-12-11 | Warnings | M015 |
| LMX5 | LIDOCAINE | Ferndale Laboratories, Inc. | 34f8ed6b-4a52-4a99-9c1b-254196dc29b0 | 2025-12-10 | Warnings | M015 |
| PURA | WITCH HAZEL | Mypura.com Limited | 1523f52f-6a5b-a12d-e063-6294a90a4496 | 2025-12-05 | Warnings | M015 |
| Menthol and Zinc Oxide | MENTHOL AND ZINC OXIDE | Marlex Pharmaceuticals, Inc. | c24e2dab-cab4-38f4-e053-2995a90aabae | 2025-12-04 | Warnings | M015 |
| CAREALL Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | New World Imports, Inc | 7913bd41-a606-4ca6-b69f-2717c2f54b07 | 2025-12-01 | Warnings | M015 |
| Dr Butlers Hemorrhoid and Fissure PF | LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25 | Beyond Health P.A. | f526199e-5c9e-7a3c-e053-2a95a90aa98e | 2025-11-26 | Warnings | M015 |
| Meicated Wipe | WITCH HAZEL | Diamond Wipes International, Inc | 4458c80c-d013-55ba-e063-6394a90a6b39 | 2025-11-24 | Warnings | M015 |
| Hemorrhoidal Cream | GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM | Trifecta Pharmaceuticals Usa Llc | 804d7b1f-1be8-50c9-e053-2a91aa0a35d0 | 2025-11-18 | Warnings | M015 |
| Launch Medical | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 293ef514-44c1-43ac-9a81-c30e34ad39e5 | 2025-11-12 | Warnings | M015 |
| FARGELIN HEMORRHOIDAL | CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE | MADISON ONE ACME INC | 6844ad63-512d-496a-9458-011894185b0d | 2025-11-10 | Warnings | M015 |
| Hazel Perineal Healing Foam | WITCH HAZEL | Jiangsu Senwo Medical Technology Co., Ltd. | 314b75cb-affe-a248-e063-6294a90a47b7 | 2025-11-07 | 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 |