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 |
|---|---|---|---|---|---|---|
| Hemorrhoid Pain Relief | LIDOCAINE | Telebrands Corp | 04164425-ca3b-ef24-e063-6294a90a59d8 | 2024-11-20 | Warnings | M015 |
| Hempvana Maximum Strength Pain Relief Topical Anesthetic | LIDOCAINE | Telebrands Corp | f525075a-d7ee-dad0-e053-2a95a90a6f3f | 2024-11-20 | Warnings | M015 |
| Curist Lidocaine Numbing Relief | LIDOCAINE | Little Pharma, Inc. | bff3c422-a0df-6196-e053-2a95a90af033 | 2024-11-20 | Warnings | M015 |
| Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum | LIDOCAINE 5% | Telebrands Corp | 2774ec41-7366-ac8c-e063-6394a90a1ee2 | 2024-11-20 | Warnings | M015 |
| Walgreens Anorectal Lidocaine Cream | 5% LIDOCAINE | Walgreens Company | 3052fac7-fd68-43f4-9950-8c07288a6b6d | 2024-11-20 | Warnings | M015 |
| Lidocaine Anorectal | LIDOCAINE | Patrin Pharma, Inc | 456d41fe-8449-4980-9291-d7a3b65a900d | 2024-11-13 | Warnings | M015 |
| MyDerm | PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL, | Inspec Solution LLC. | 2618eba1-9308-a666-e063-6394a90ac3d2 | 2024-11-04 | Warnings | M015 |
| Granulotion Medicated | MENTHOL, ZINC OXIDE | GL HEALTH, INC. | 01701780-b160-415b-b34d-362237179475 | 2024-10-29 | Warnings | M015 |
| rexall hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Dolgencorp Inc | 0415c51b-5a12-49d4-8968-0131ddb85545 | 2024-10-23 | Warnings | M015 |
| Exchange Select Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Army & Air Force Exchange Service | 8155ed74-9412-498f-998c-4a29c46e934f | 2024-10-23 | Warnings | M015 |
| Leader Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | c4814524-0f4c-4351-a431-5b4b6431fd28 | 2024-10-23 | Warnings | M015 |
| basic care hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Amazon.com Services LLC | 617d9213-31f0-4c71-be0c-7961b96e5143 | 2024-10-23 | Warnings | M015 |
| Signature Care Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Safeway | e74b71a1-915d-4e5b-b548-d5cce7945dbd | 2024-10-23 | Warnings | M015 |
| Equaline Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | d29b7824-ff9e-4875-b3de-92721c8add0e | 2024-10-23 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Publix Super Markets Inc | a241cb37-7007-4fd8-a12e-f3fc6d6f780e | 2024-10-22 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Kroger Company | d44ca22a-dc20-454d-99aa-403a8c7a3e00 | 2024-10-22 | Warnings | M015 |
| rugby hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Rugby Laboratories | c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b | 2024-10-22 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Meijer Distribution Inc | 1431397e-3515-4794-a494-70667948e14c | 2024-10-18 | Warnings | M015 |
| signature care hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Safeway | afcf68cf-f187-44d3-ad91-b1e79b182bc6 | 2024-10-17 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | H E B | 1435432d-5ff2-468b-808d-fb0c99a0717b | 2024-10-17 | 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 |