Thera Plus Hemorrhoidal
- Product NDC
- 80684-210
- 11-digit product format
- 806840210
- Labeler code
- 80684
- Product ID
- 80684-210_4ee1f506-399b-78b9-e063-6394a90ad640
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fourstar Group USA, Inc.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-12
- Substance
- GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; WHITE PETROLATUM
- Active strength
- 144; 2.5; 10; 150 mg/g; mg/g; mg/g; mg/g
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Thera Plus Hemorrhoidal
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLYCERIN | 144 mg/g |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
| WHITE PETROLATUM | 150 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PDC6A3C0OX | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
| B6E5W8RQJ4 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1293649 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5d63bf97-29d2-4c71-97c3-85f425e86207 | 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 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80684-210-01 | Thera Plus Hemorrhoidal | 26 g in 1 TUBE | CREAM | 26 | 1 |
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 |
|---|---|---|---|---|---|---|
| DRMITSUI MEDICAL HAEMORRHOID | PHENYLEPHRINE HCI WITCH HAZEL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 51720221-893b-cade-e063-6394a90adaec | 2026-05-10 | Warnings | M015 |
| Glycerin | GLYCERIN SUPPOSITORIES | Neilmed Pharmaceuticals Inc. | 374a2ca3-ee04-09a7-e063-6394a90ab760 | 2026-05-05 | Warnings | M015 |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | 32ab24b4-dcec-4a09-e054-00144ff88e88 | 2026-04-30 | Warnings | M015 |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | c2c0cb17-401a-4ba2-aa04-64c9b43cd21b | 2026-04-30 | Warnings | M015 |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | e840fba4-86ff-9da0-e053-2995a90a221a | 2026-04-30 | Warnings | M015 |
| FAMILY Wellness MEDICATED HEMORRHOIDAL WIPES | WITCH HAZEL | Family Dollar Stores, Inc | 3f6f68c0-787a-48eb-b042-d4df90ea7e03 | 2026-04-17 | Warnings | M015 |
| Equaline Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | a6ed1987-37ad-4bfd-8cea-f03426953f5a | 2026-04-16 | Warnings | M015 |
| Verdibliss HEMORRHOID RELIEF OINTMENTS | LIDOCAINE, PHENYLEPHRINE | Guangdong Quadrant Ecological Technology Co., Ltd. | 4f1634d5-7667-b354-e063-6394a90a34e7 | 2026-04-10 | Warnings | M015 |
| Hemorrhoidal Cream with Lidocaine | GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM | Trifecta Pharmaceuticals Usa Llc | 4f1ef866-c4af-989b-e063-6294a90a148e | 2026-04-10 | Warnings | M015 |
| Thera Plus Hemorrhoidal | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM | Fourstar Group USA, Inc. | 5d63bf97-29d2-4c71-97c3-85f425e86207 | 2026-04-07 | Warnings | M015 80684-210 |
| Walgreens Pain Relief with Lidocaine | LIDOCAINE, PHENYLEPHRINE HCL | Walgreens Co | 3ce78f2f-0264-f406-e063-6294a90a7e03 | 2026-04-01 | Warnings | M015 |
| Lidocaine | LIDOCAINE | YYBA Corp | 5256a84a-8dac-8fd4-e063-6294a90a616c | 2026-04-01 | Warnings | M015 |
| Hemorrhoidal | LIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUM | Walgreens Co | 3d213ba8-3cbe-11c4-e063-6394a90ae016 | 2026-03-30 | Warnings | M015 |
| Critic Aid Skin | ZINC OXIDE | Coloplast Corp | caaac1f0-437d-4185-8670-9f11b9cefe63 | 2026-03-30 | Warnings | M015 |
| CVS Topical Analgesic Hemorrhoidal | DIBUCAINE | CVS PHARMACY,INC | b9e20531-3444-4955-b1d3-bb112340d230 | 2026-03-27 | Warnings | M015 |
| Walgreens Moisture Barrier | WALGREENS MOISTURE BARRIER | Walgreens | 44fc098c-1f5f-bf82-e063-6294a90a1405 | 2026-03-25 | Warnings | M015 |
| Lidocaine | LIDOCAINE | YYBA Corp | 472fe0d1-31a1-fded-e063-6394a90a4a66 | 2026-03-25 | Warnings | M015 |
| Hemorrhoid Relief Cream | LIDOCAINE 5% ANORECTAL | ALAINA HEALTHCARE PRIVATE LIMITED | 53b2c3b0-d729-44d6-bc64-a9e1c9351877 | 2026-03-23 | Warnings | M015 |
| LIDOCAINE | LIDOCAINE | YYBA Corp | 4db609cc-f329-62a4-e063-6394a90aefc1 | 2026-03-23 | Warnings | M015 |
| Topical Hemorrhoid Relief Gel | MENTHOL, UNSPECIFIED FORM | Yantai Aien Biotechnology Co., Ltd. | 4d6e6667-ab1c-de7c-e063-6294a90a0b9b | 2026-03-20 | Warnings | M015 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1293649 | glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal Cream | PSN | 5d63bf97-29d2-4c71-97c3-85f425e86207 | 1 |
| 1293649 | glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream | SCD | 5d63bf97-29d2-4c71-97c3-85f425e86207 | 1 |
| 1293649 | glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal Cream | SY | 5d63bf97-29d2-4c71-97c3-85f425e86207 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80684-210-01 | 80684021001 | 26 g in 1 TUBE (80684-210-01) | 26 g | 2026-03-12 | No | No | Current |