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 |
|---|---|---|---|---|---|---|
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 1cada0ae-3f0f-441c-a633-faa0a3009d2b | 2026-02-05 | Warnings | M015 |
| Numbing Cream | LIDOCAINE | Sainite Trading Shenzhen Co., Ltd. | 49fcbe81-34b6-5906-e063-6294a90aa65b | 2026-02-04 | Warnings | M015 |
| Perineal Cooling Pad Liners | FRIDA MOM PERINEAL COOLING PAD LINERS | Fridababy, LLC | e9d33d92-34ee-b639-e053-2a95a90a9f36 | 2026-02-04 | Warnings | M015 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Sportpharm LLC | 88e3624d-b8bb-4e65-9250-4c51d2bbed16 | 2026-02-03 | Warnings | M015 |
| careone hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | American Sales Company | 46794d2e-8fe6-490d-9cfa-ba9b6c209ad6 | 2026-01-29 | Warnings | M015 |
| LUBRICAINE 5 | LIDOCAINE 5% | ESBA LABORATORIES INC. | 9d98afbf-11ce-745b-e053-2a95a90abc14 | 2026-01-28 | Warnings | M015 |
| foster and thrive hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 9da843f2-e88c-432e-b091-a6acf81d856b | 2026-01-22 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | HyVee Inc | bf1beca0-cc9b-4100-9db7-77f2d1e5497c | 2026-01-21 | Warnings | M015 |
| GRANULOTION Hemorrhoidal | MENTHOL, ZINC OXIDE | GL Health, Inc. | 1a32741c-5e4a-40e5-b15a-8233c5bdb92b | 2026-01-19 | Warnings | M015 |
| Hydroseptine | ZINC OXIDE, MENTHOL | AKRON PHARMA INC | 5359d92e-641e-4076-9d91-18daee58a30e | 2026-01-19 | Warnings | M015 |
| Hemorrhoidal Cream | HEMORRHOIDAL CREAM | Walgreens | 1ac2b2ae-c090-483b-ad2c-1374552add4a | 2026-01-15 | Warnings | M015 |
| Walgreens | HEMORRHOIDAL PAIN RELIEF | Walgreens | b0b1ce47-9fa4-4505-8f38-39a0d500e9f6 | 2026-01-15 | Warnings | M015 |
| Hemorrhoidal Cream | HEMORRHOIDAL CREAM | Walgreens | 4276ddad-2363-462a-bb97-574f946ec3f0 | 2026-01-15 | Warnings | M015 |
| Walgreens | HEMORRHOIDAL COOLING GEL | Walgreens | 1277d2e8-2a5e-23f5-e063-6294a90a69b0 | 2026-01-15 | Warnings | M015 |
| Hemorrhoid and Fissure | GLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12% | FlexiGo Inc | 48697377-61c0-1b0a-e063-6294a90a3293 | 2026-01-15 | Warnings | M015 |
| MEDPURA Vitamin A and D Vitamin A and D | MEDPURA VITAMIN A AND D | Akron Pharma Inc. | 38cc2317-691b-4657-af05-c67623eba760 | 2026-01-14 | Warnings | M015 |
| Walgreens Hemorrhoidal | HEMORRHOIDAL RECTAL SUPPOSITORIES | Walgreens | 2dd710ac-ab04-4a24-826f-b5a44d058168 | 2026-01-14 | Warnings | M015 |
| Walgreens Hemorrhoidal | HEMORRHOIDAL RECTAL SUPPOSITORIES | Walgreens | ca98dea5-767d-49a8-887b-d96cad487fc4 | 2026-01-14 | Warnings | M015 |
| Walgreens Moisture Barrier | MENTHOL, AND ZINC OXIDE | Walgreen Company | a6db6f13-4e02-47dc-aef6-a804506c3d8b | 2026-01-14 | Warnings | M015 |
| GNP Hemorrhoidal Maximum Strength | HEMORRHOIDAL | Amerisourcebergen Drug Corporation | 24103355-cd72-55b0-e063-6394a90a90ec | 2026-01-14 | 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 |