Drs pharmacy HEMORRHOIDAL
- Product NDC
- 80489-953
- 11-digit product format
- 804890953
- Labeler code
- 80489
- Product ID
- 80489-953_563698a1-f78d-c496-e063-6294a90a6fe4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- phenylephrine HCL, witch hazel
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- OL PHARMA TECH, LLC Drs PHARMACY
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-11-01
- Substance
- PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL
- Active strength
- 749; 2.5; 140 mg/g; mg/g; mg/g
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80489-953-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80489-953-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80489-953-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80489-953-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80489-953-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80489-953-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80489-953-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 80489-953-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 80489-953-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 80489-953-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 80489-953-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 80489-953-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Drs pharmacy HEMORRHOIDAL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PETROLATUM | 749 mg/g |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/g |
| MINERAL OIL | 140 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4T6H12BN9U | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| T5L8T28FGP | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1372298 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 164169b9-0627-9d1a-e063-6294a90ac46d | 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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1372298 | mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment | PSN | 164169b9-0627-9d1a-e063-6294a90ac46d | 2 |
| 1372298 | mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment | SCD | 164169b9-0627-9d1a-e063-6294a90ac46d | 2 |
| 1372298 | mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment | SY | 164169b9-0627-9d1a-e063-6294a90ac46d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80489-953-01 | 80489095301 | 1 TUBE in 1 CARTON (80489-953-01) / 28.3 g in 1 TUBE | 1 tube | 2021-11-01 | No | No | Current |