Preparation H
- Product NDC
- 0573-2884
- 11-digit product format
- 005732884
- Labeler code
- 0573
- Product ID
- 0573-2884_155865d1-91f7-90d4-e063-6394a90a5945
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cocoa butter, phenylephrine hydrochloride, and witch hazel
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0573-2884-12 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 0573-2884-12 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 0573-2884-12 | bd6a592717d7… | 303034d00443… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Preparation H
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2f370875-0225-47b7-b43f-8fa4600d2a0e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0573-2884-12 | 2023-02-08 | C162847 | 48780-1 | d6a99b39-6597-a426-e053-dadaa90af4c2 | Drug Facts |
| 0573-2884-12 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6597-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0573-2884-12 | Preparation H | 1 in 1 CARTON | KIT | 1 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1438497 | cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository | PSN | 2f370875-0225-47b7-b43f-8fa4600d2a0e | 7 |
| 844379 | witch hazel 50 % Medicated Pad | PSN | 2f370875-0225-47b7-b43f-8fa4600d2a0e | 7 |
| 1438497 | cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository | SCD | 2f370875-0225-47b7-b43f-8fa4600d2a0e | 7 |
| 844379 | witch hazel 500 MG/ML Medicated Pad | SCD | 2f370875-0225-47b7-b43f-8fa4600d2a0e | 7 |
| 1438497 | cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository | SY | 2f370875-0225-47b7-b43f-8fa4600d2a0e | 7 |
| 844379 | witch hazel 50 % Medicated Pad | SY | 2f370875-0225-47b7-b43f-8fa4600d2a0e | 7 |
| 844379 | witch hazel 50 % Medicated Wipes | SY | 2f370875-0225-47b7-b43f-8fa4600d2a0e | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0573-2884-12 | 00573288412 | 1 KIT in 1 CARTON (0573-2884-12) * 12 SUPPOSITORY in 1 BLISTER PACK * 4 CLOTH in 1 APPLICATOR | 1 kit | 2015-07-01 | 0000-00-00 | No | No | Current |