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 |
|---|---|---|---|---|---|---|
| Calmoseptine | ANORECTAL OINTMENT | Calmoseptine Inc. | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 2025-01-13 | Warnings | M015 |
| Dibucaine | DIBUCAINE | Akron Pharma Inc. | 60469e43-ab6f-46d3-a1df-00e58275f565 | 2025-01-12 | Warnings | M015 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Chain Drug Marketing Association Inc. | 2b490a08-149d-76ab-e063-6394a90a084f | 2025-01-09 | Warnings | M015 |
| Drs. pharmacy HEMORRHOIDAL COOLING | PHENYLEPHRINE HCL, WITCH HAZEL | OL PHARMA TECH, LLC Drs PHARMACY | d6f6b482-d85d-001c-e053-2995a90ad98c | 2025-01-09 | Warnings | M015 |
| Hemorrhoidal Cream with Aloe | GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM | Chain Drug Marketing Association | 2b33c710-ac17-20f9-e063-6294a90ad29c | 2025-01-08 | Warnings | M015 |
| THE SOLUTION | LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE | SCALP TECH INC | df51623c-e0b6-8e86-e053-2995a90a59b2 | 2025-01-08 | Warnings | M015 |
| frida mom Perineal Cooling Pad Liners | WITCH HAZEL | Fridababy, LLC | a461ff3d-e115-4f15-a545-bacb502ff6cd | 2024-12-30 | Warnings | M015 |
| frida mom Postpartum Recovery Essentials | WITCH HAZEL | Fridababy, LLC | 2d26c6f2-5d31-4c07-9f40-2fbfcfbf1234 | 2024-12-30 | Warnings | M015 |
| frida mom Perineal Healing | WITCH HAZEL | Fridababy, LLC | 6a58e2a8-c4d5-4078-b5f4-28504de1f020 | 2024-12-30 | Warnings | M015 |
| frida mom Labor and Delivery Plus Postpartum Recovery | WITCH HAZEL | Fridababy, LLC | 4b5fc312-4c8c-4396-a70c-b1ed129038c7 | 2024-12-30 | Warnings | M015 |
| Tucks Triple Relief Hemorrhoidal | WHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Blistex Inc. | bf892e90-2d9b-4fa0-8ee4-8a2736be6c30 | 2024-12-24 | Warnings | M015 |
| BLISS GVS HEMORRHOIDAL | PHENYLEPHRINE HCL | Bliss GVS Pharma Limited | fceea303-2ea0-10e9-e053-6294a90a5492 | 2024-12-21 | Warnings | M015 |
| Dibucaine | DIBUCAINE 1% | Geri-Care Pharmaceuticals, Corp | afe88610-5cac-960e-e053-2a95a90a7ba4 | 2024-12-20 | Warnings | M015 |
| Hemorroidal Cooling gel | PHENYLEPHRINE, WITCH HAZEL | Pharmacy Value Alliance, LLC | 7276aab8-0297-2a55-e053-2a91aa0a8d21 | 2024-12-20 | Warnings | M015 |
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Pharmacy Value Alliance, LLC | 3803a61b-308a-14a9-e054-00144ff88e88 | 2024-12-20 | Warnings | M015 |
| Bliss GVS Hemorrhoidal | HARD FAT, PHENYLEPHRINE HCL | Bliss GVS Pharma Limited | 88c49f6c-2a48-2dae-e053-2a95a90af20a | 2024-12-19 | Warnings | M015 |
| Rectal Care Cream Revivol | LIDOCAINE 5% | Derma Care Research Labs | a1c75161-f84a-e996-e053-2a95a90ac0c5 | 2024-12-19 | Warnings | M015 |
| DCH Numbing Relief | LIDOCAINE 5% | Derma Care Research Labs, LLC | ffd70a31-7d0c-d2d0-e053-6394a90a8674 | 2024-12-19 | Warnings | M015 |
| DCH Hemorrhoidal | GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25% | Derma Care Research Labs, LLC | 0050701f-4393-3f01-e063-6394a90a4e0e | 2024-12-19 | Warnings | M015 |
| Moshe Numbing Hemorrhoidal | LIDOCAINE 5% | Derma Care Research Labs | fbd5b488-1921-e9b7-e053-6294a90aba70 | 2024-12-19 | 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 |