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 |
|---|---|---|---|---|---|---|
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | 4eb3c9ac-268a-5246-e054-00144ff88e88 | 2025-06-09 | Warnings | M015 |
| Bunnies Bum Anorectal Numbing | LIDOCAINE | FloCal Distributors LLC | 3712e151-d171-1c5d-e063-6294a90a36c0 | 2025-06-08 | Warnings | M015 |
| RECOVERY Numbing | LIDOCAINE HCL | Renu Laboratories, LLC | e4e05cae-56a6-b2b3-e053-2a95a90a104b | 2025-06-06 | Warnings | M015 |
| Hemorrohoid Master Cream | LIDOCAINE, PHENYLEPHRINE HCL | Ebanel Laboratories, Inc. | 36eccc74-107e-3914-e063-6294a90a1856 | 2025-06-06 | Warnings | M015 |
| Numb 520 | LIDOCAINE | Ebanel Laboratories, Inc | 36c9988b-9e61-ebbf-e063-6394a90a4114 | 2025-06-04 | Warnings | M015 |
| Hemorrhoid Master | LIDOCAINE, PHENYLEPHRINE HCL | Clinical Resolution Laboratory, Inc. | 36caf20d-116a-f86a-e063-6294a90a7b62 | 2025-06-04 | Warnings | M015 |
| Quick Numb | LIDOCAINE | Clinical Resolution Laboratory, Inc. | 351b95a6-e038-d9aa-e063-6294a90a4172 | 2025-05-29 | Warnings | M015 |
| Dibucaine Topical Anesthetic 1% Hemorrhoidal | DIBUCAINE | Rugby Laboratories Inc. | f23c8cd1-98f9-41cd-84d4-cf01c2ede29a | 2025-05-29 | Warnings | M015 |
| The Femme Fix Hemorrhoid Treatment | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | POPPY COLLECTIVE LLC | 5217b5d9-b835-4428-a6b3-e6b255630742 | 2025-05-27 | Warnings | M015 |
| MAXOCAINE Topical Anesthetic Anorectal | LIDOCAINE | PRIME COMMERCE, LLC | 26e8c867-8cb8-4a25-91b1-da45a1edd09a | 2025-05-27 | Warnings | M015 |
| Numb25 | LIDOCAINE | Ebanel Laboratories, Inc. | 35107403-55ae-c627-e063-6394a90a0b5c | 2025-05-27 | Warnings | M015 |
| Numb 520 | LIDOCAINE | Ebanel Laboratories, Inc | 350e4d5e-dac7-ae4e-e063-6394a90a76b4 | 2025-05-27 | Warnings | M015 |
| Numb25 | LIDOCAINE 5% | Ebanel Laboratories, Inc | 350fd302-8fd5-5288-e063-6294a90aa382 | 2025-05-27 | Warnings | M015 |
| Numb 520 | LIDOCAINE | Ebanel Laboratories, Inc | 35095bed-0e91-c44a-e063-6294a90add6e | 2025-05-27 | Warnings | M015 |
| Numb520 | LIDOCAINE | Clinical Resolution Laboratory, Inc. | a0411950-c6ee-4427-acb6-3cef58b0e93e | 2025-05-15 | Warnings | M015 |
| Numb25 | LIDOCAINE | Clinical Resolution Laboratory, Inc. | cfcb839d-47b4-4925-bb30-97b64d20d2b3 | 2025-05-15 | Warnings | M015 |
| Numb520 | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | Clinical Resolution Laboratory, Inc. | 65d3b614-361d-4fb9-9583-a95be754bc82 | 2025-05-15 | Warnings | M015 |
| Chamosyn | BARRIER CREAM | Links Medical Products | f9dfb2d7-4684-4525-994e-1e0ff90413d9 | 2025-05-08 | Warnings | M015 |
| LANOZEM HEMORRHOIDAL | MENTHOL, PETROLATUM | Sod-e Biotech Ltd | 34901e83-8f24-8460-e063-6394a90a2744 | 2025-05-07 | Warnings | M015 |
| PREPARATION H | PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 96d2e0e7-2de0-4660-9ffd-9edb2ad224d8 | 2025-04-18 | 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 |