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 |
|---|---|---|---|---|---|---|
| Family wellness | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | FRONT PHARMACEUTICAL PLC | cfdd61e3-e12e-491c-b2a8-90fae19e8870 | 2023-10-27 | Warnings | M015 |
| Family Wellness | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM | FRONT PHARMACEUTICAL PLC | eb1785f4-5876-443b-b175-9b59d65d1a48 | 2023-10-26 | Warnings | M015 |
| CVS Health Hemorrhoidal Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | FRONT PHARMACEUTICAL PLC | cb448d78-553c-4e65-80c5-d4b31d7b3661 | 2023-10-26 | Warnings | M015 |
| Family Wellness | PHENYLEPHRINE HCL, PETROLATUM, MINERAL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bfa195d7-d87f-43b5-bbf1-7ec3a451de05 | 2023-10-25 | Warnings | M015 |
| MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots | LIDOCAINE | CVS PHARMACY, INC | 82aa128a-44cd-4907-b0f7-8a31e086d3e6 | 2023-10-25 | Warnings | M015 |
| TheraPlus Plus | PHENYLEPHRINE HCI | Zhejiang Jingwei Pharmaceutical Co., Ltd. | edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d | 2023-10-25 | Warnings | M015 |
| Assured Bikini Smooth Cream | LIDOCAINE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fb9ddde3-3f40-467e-8aff-26570144f0fc | 2023-10-25 | Warnings | M015 |
| Hemorrhoidal Cream | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM | Cardinal Health 110, LLC. dba Leader | 85a51d5c-679e-1959-e053-2a91aa0a76d5 | 2023-10-25 | Warnings | M015 |
| Family Wellness | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fde9cd90-d63c-4058-b46e-511fecea36ec | 2023-10-24 | Warnings | M015 |
| Lidocaine 5% | LIDOCAINE | Apnar Pharma LP | ceedce20-5723-5a9a-e053-2a95a90a17a1 | 2023-10-21 | Warnings | M015 |
| Numquick Topical Analgesic | EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE | Unit Dose, Ltd. | 3f64cbd3-6745-4397-9767-3adc3b301e0e | 2023-10-19 | Warnings | M015 |
| Healquick Tattoo Balm | PETROLATUM | Unit Dose, Ltd. | 96f92c82-a79a-4d7e-ba0c-5ea67e2b6e86 | 2023-10-19 | Warnings | M015 |
| Numpot Topical Anesthetic | LIDOCAINE, PETROLATUM | Unit Dose, Ltd. | 9143b50b-7d76-4545-aa2e-1bb77ffb44ae | 2023-10-19 | Warnings | M015 |
| Microcaine Topical Analgesic | LIDOCAINE | Unit Dose, Ltd. | 5e8fa8b5-0524-4201-91e1-83e59a8f0415 | 2023-10-19 | Warnings | M015 |
| Numstick | PETROLATUM, LIDOCAINE | Unit Dose, Ltd. | 127bbd87-5402-4da2-abf3-dac6367735ec | 2023-10-18 | Warnings | M015 |
| ADVANCED NUMB Topical Anesthetic | LIDOCAINE HYDROCHLORIDE | Uber Scientific, LLC | 859d1cad-badf-4c42-9b08-daacb3fae8b4 | 2023-10-13 | Warnings | M015 |
| Hemorrhoidal Pain Relief with Aloe and VitaminE | HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE | NeilMed pharmaceuticals Inc. | 076b5021-8ba0-0204-e063-6294a90a3337 | 2023-10-11 | Warnings | M015 |
| Zensa Numbing Gel | LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25% | Alera Skin Care Products Inc. | 065a6eec-3896-0da8-e063-6394a90a849d | 2023-09-27 | 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 |