Rectal Care Cream
- Product NDC
- 69168-484
- 11-digit product format
- 691680484
- Labeler code
- 69168
- Product ID
- 69168-484_ed430339-1b70-43ff-9f79-841e242aaa6f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Rectal Care Cream
- Dosage form
- CREAM
- Route
- RECTAL; TOPICAL
- Labeler
- Allegiant Health
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-07
- Substance
- LIDOCAINE
- Active strength
- 5 g/100g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Rectal Care Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE | 5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 98PI200987 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1366789 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ce585082-ad39-4b6f-a756-0d9a81a13eb8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-484-02 | Rectal Care Cream | 28 g in 1 TUBE | CREAM | 28 | 2 | |
| 69168-484-02 | Rectal Care Cream | 1 in 1 CARTON | CREAM | 1 | 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 |
|---|---|---|---|---|---|---|
| Pranicura 5 | GLYCERIN, KAOLIN, CALAMINE, MENTHOL | Pranicura Products LLC | af520a58-3f3c-4d28-a41f-3ed8f74da095 | 2025-11-04 | Warnings | M015 |
| ProCure ClamaPlex | ZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335 | Twin Med LLC | 3d366857-5178-9032-e063-6294a90a40f3 | 2025-11-01 | Warnings | M015 |
| GNP Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCL | Amerisource Bergen | b0f0ef97-9add-717f-e053-2a95a90a0eb0 | 2025-10-30 | Warnings | M015 |
| REMEDY Calazime Skin Protectant | CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 2025-10-30 | Warnings | M015 |
| Hemorrhoid Anesthetic | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Universal Distribution Center LLC | 186c2d32-e8c5-d13d-e063-6294a90a2b0e | 2025-10-30 | Warnings | M015 |
| Workvie | LIDOCAINE HCL, MENTHOL | Marketites LLC | aebaffb5-58dd-ebd5-e053-2a95a90a14ed | 2025-10-29 | Warnings | M015 |
| hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | Publix Super Markets Inc | 354a640c-bc7e-45c8-9df0-8b5b01767f5c | 2025-10-29 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Pharmacy Value Alliance LLC | 903b77fc-02bf-73b6-e053-2a95a90ad4cc | 2025-10-24 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | CVS Pharmacy | 845fc11b-707d-2027-e053-2991aa0a1c8a | 2025-10-24 | Warnings | M015 |
| Calmol 4 | ZINC OXIDE AND COCOA BUTTER | Resical Inc. | 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b | 2025-10-24 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Amerisourcebergen Drug Corporation | 231a850a-bad6-9a30-e063-6394a90a0fdc | 2025-10-24 | Warnings | M015 |
| Signature Care Hemorrhoidal Cream (with applicator) | PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUM | BETTER LIVING BRANDS, LLC | b026a386-5e38-52ed-e053-2a95a90a6b0e | 2025-10-24 | Warnings | M015 |
| Americaine | BENZOCAINE | Insight Pharmaceuticals LLC | d13c022f-2f91-40b4-bd66-0cfc0e147a5f | 2025-10-23 | Warnings | M015 |
| Winco Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE | Winco Foods, LLC | 04ca3ef1-fc6b-4683-b236-a75afc031fb5 | 2025-10-23 | Warnings | M015 |
| Signature Care Medicated Cooling | WITCH HAZEL | Better Living Brands, LLC | b35dc719-a5a2-4839-870d-25313d3f7c9b | 2025-10-22 | Warnings | M015 |
| Family Care Hemorrhoidal | MINERAL OIL | United Exchange Corp | 04375257-f4f3-48c3-a338-de43298b95eb | 2025-10-22 | Warnings | M015 |
| Family Wellness Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL | Family Dollar Services, Inc | fe3293bc-80b5-b60a-e053-6394a90a4ede | 2025-10-22 | Warnings | M015 |
| Xesso Rear Comfort Glide | LIDOCAINE | PREMIUM NATURAL COSMETICS INC | e9eb262e-a1c1-7d5c-e053-2a95a90a7c9f | 2025-10-22 | Warnings | M015 |
| Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 41a6d309-2722-1738-e063-6294a90a8a70 | 2025-10-21 | Warnings | M015 |
| DERMOSCRIBE ICHYBUM | HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE | DERMOSCRIBE PTY LTD | 134a88a1-13e5-4da0-8270-c380b57aaeb7 | 2025-10-17 | Warnings | M015 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1366789 | lidocaine 5 % Rectal Cream | PSN | ce585082-ad39-4b6f-a756-0d9a81a13eb8 | 2 |
| 1366789 | lidocaine 50 MG/ML Rectal Cream | SCD | ce585082-ad39-4b6f-a756-0d9a81a13eb8 | 2 |
| 1366789 | lidocaine 5 % Rectal Cream | SY | ce585082-ad39-4b6f-a756-0d9a81a13eb8 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69168-484-02 | 69168048402 | 1 TUBE in 1 CARTON (69168-484-02) / 28 g in 1 TUBE | 1 tube | 2025-07-07 | No | No | Current |