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 |
|---|---|---|---|---|---|---|
| CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots | LIDOCAINE | CVS PHARMACY, INC | caef51a8-76e9-42b3-a160-c54f62b47de1 | 2026-01-05 | Warnings | M015 |
| CVS Maximum OTC Strength Hemorrhoidal with Aloe | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM | CVS PHARMACY,INC | b55c63fb-5dfa-4567-8192-58f403868837 | 2026-01-02 | Warnings | M015 |
| HemRid Anorectal Cream | LIDOCAINE | KKA & Associates LLC | dbeb4325-3e85-1147-e053-2995a90a2160 | 2025-12-31 | Warnings | M015 |
| ElixirCurozole | CLOTRIMAZOLE | ELIXIR HEALTHCARE USA, LLC. | 0c468a9e-d092-4704-b742-92ecd9918209 | 2025-12-26 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | 5162baee-0d63-494e-8046-459437b85348 | 2025-12-25 | Warnings | M015 |
| HEMORRHOIDAL | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE | Safeway | 3e6728b6-26e3-4287-8ba6-e27f305cd93b | 2025-12-20 | Warnings | M015 |
| PREPARATION H | PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 40fde50a-3cc0-4286-9b33-8f3912254c33 | 2025-12-18 | Warnings | M015 |
| ElixirLidoFast Rapid Relief | GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE | ELIXIR HEALTHCARE USA, LLC. | 45de9dfa-6c89-1eae-e063-6294a90a4dac | 2025-12-13 | Warnings | M015 |
| topcare hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Topco Associates LLC | 81a3546b-5099-4b9a-b774-b3e79316b267 | 2025-12-13 | Warnings | M015 |
| Kroger Hemorrhoid | GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL | Kroger Company | 45b2dd86-7fb0-07bf-e063-6394a90a1884 | 2025-12-11 | Warnings | M015 |
| LMX5 | LIDOCAINE | Ferndale Laboratories, Inc. | 34f8ed6b-4a52-4a99-9c1b-254196dc29b0 | 2025-12-10 | Warnings | M015 |
| PURA | WITCH HAZEL | Mypura.com Limited | 1523f52f-6a5b-a12d-e063-6294a90a4496 | 2025-12-05 | Warnings | M015 |
| Menthol and Zinc Oxide | MENTHOL AND ZINC OXIDE | Marlex Pharmaceuticals, Inc. | c24e2dab-cab4-38f4-e053-2995a90aabae | 2025-12-04 | Warnings | M015 |
| CAREALL Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | New World Imports, Inc | 7913bd41-a606-4ca6-b69f-2717c2f54b07 | 2025-12-01 | Warnings | M015 |
| Dr Butlers Hemorrhoid and Fissure PF | LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25 | Beyond Health P.A. | f526199e-5c9e-7a3c-e053-2a95a90aa98e | 2025-11-26 | Warnings | M015 |
| Meicated Wipe | WITCH HAZEL | Diamond Wipes International, Inc | 4458c80c-d013-55ba-e063-6394a90a6b39 | 2025-11-24 | Warnings | M015 |
| Hemorrhoidal Cream | GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM | Trifecta Pharmaceuticals Usa Llc | 804d7b1f-1be8-50c9-e053-2a91aa0a35d0 | 2025-11-18 | Warnings | M015 |
| Launch Medical | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 293ef514-44c1-43ac-9a81-c30e34ad39e5 | 2025-11-12 | Warnings | M015 |
| FARGELIN HEMORRHOIDAL | CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE | MADISON ONE ACME INC | 6844ad63-512d-496a-9458-011894185b0d | 2025-11-10 | Warnings | M015 |
| Hazel Perineal Healing Foam | WITCH HAZEL | Jiangsu Senwo Medical Technology Co., Ltd. | 314b75cb-affe-a248-e063-6294a90a47b7 | 2025-11-07 | 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 |