Over-the-counter drug · OTC MONOGRAPH DRUG
Hydrocortisone with aloe (Hydrocortisone) NDC 21922-097
Hydrocortisone 1 g/100g · Cream · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-097-04 | 21922009704 | 1 TUBE in 1 CARTON (21922-097-04) / 14 g in 1 TUBEMarketed from Feb 26, 2025 | |
| 21922-097-05 | 21922009705 | 1 TUBE in 1 CARTON (21922-097-05) / 28 g in 1 TUBEMarketed from Feb 26, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hydrocortisone with aloe
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 21922-097_12a1774d-a97e-4787-b6b1-8e8cd40b7b70SPL ID 12a1774d-a97e-4787-b6b1-8e8cd40b7b70SPL set ID 12a1774d-a97e-4787-b6b1-8e8cd40b7b70RxCUI 106258UNII WI4X0X7BPJUPC 0321922097054, 0321922097047
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N421922009704followed by a unit qualifier and the quantityPackage 21922-0097-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
USE(S) ■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to ■ eczema ■ psoriasis ■ insect bites ■ poison ivy, oak sumac ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should be only under the advice and supervision of a doctor
Excerpt only. Read the full label for complete information.
About NDC 21922-097
- What is NDC 21922-097?
- 21922-097 is the product NDC for Hydrocortisone with aloe (hydrocortisone), Hydrocortisone 1 g/100g cream, listed with the FDA by Encube Ethicals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone with aloe (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocortisone with aloe?
- 11 other product NDCs are listed under this name. See all Hydrocortisone with aloe NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocortisone with aloe products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocortisone with Aloehydrocortisone cream 1/2% | Hydrocortisone .5 g/100g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-5335 | 51672-5335-02 |
| Hydrocortisone with Aloehydrocortisone cream 1% | Hydrocortisone 1 g/100g | CreamTopical | AMERISOURCE BERGEN | 46122-822 | 46122-0822-36 |
| Hydrocortisone with Aloehydrocortisone cream 1% | Hydrocortisone 1 g/100g | CreamTopical | Aldermed Inc. | 87236-003 | 87236-0003-01 |
| Hydrocortisone with Aloehydrocortisone cream 1% | Hydrocortisone 1 g/100g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-5330 | 51672-5330-0151672-5330-0251672-5330-03 |
| Hydrocortisone with Aloehydrocortisone cream 1% | Hydrocortisone 1 g/100g | CreamTopical | NuCare Pharmaceuticals, Inc. | 68071-5305 | 68071-5305-01 |
| Hydrocortisone with Aloehydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | A-S Medication Solutions | 50090-7428 | 50090-7428-00 |
| Hydrocortisone with Aloehydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1216 | 70677-1216-0170677-1216-02 |
| Hydrocortisone with aloehydrocortisone with aloe anti itch | Hydrocortisone 10.2 mg/g | CreamTopical | NeilMed Pharmaceuticals Inc. | 13709-317 | 13709-0317-0113709-0317-02 |
| Hydrocortisone with Aloehydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | TARGET Corporation | 11673-392 | 11673-0392-02 |
| Hydrocortisone with Aloehydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-2013 | 51672-2013-0151672-2013-0251672-2013-03 |
Other NDCs under M 017
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dr.Harry COMFORT ZONE Creamlidocaine 4% phenylephrine hcl 0.25% comfort zone cream | Phenylephrine hydrochloride .25 g/100g; Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-162 |
| Itch Relief Gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Pharma Nobis, LLC | 82645-901 |
| Cintheralidocaine | Lidocaine .04 g/g | OintmentCutaneous | Strand Health Group | 83295-8000 |
| Trojan Extended Pleasurebenzocaine | Benzocaine 4.5 g/60mL | SprayTopical | Church & Dwight Co., Inc. | 10237-200 |
| Lightning Products BURN RELIEFlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-070 |
| Methyl Salicylate | Methyl salicylate 250 mg/g | CreamTopical | Alexso, Inc | 50488-1015 |
| Pramoxine Itch reliefpramoxine hcl 1% | Pramoxine hydrochloride 1 g/100g | CreamTopical | CVS | 51316-141 |
| Hydrocortisone with Aloehydrocortisone cream 1/2% | Hydrocortisone .5 g/100g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-5335 |
| Biofreeze Mentholmenthol, unspecified form | Menthol, Unspecified form .05 g/g | PatchTopical | Reckitt Benckiser LLC | 59316-992 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/g | GelTopical | Safetec of America, Inc. | 61010-5000 |
| Family Care Anti-Itchhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | United Exchange Corp. | 65923-494 |
| Hydrocortisonehydrocortisone 1% | Hydrocortisone 1 g/100g | CreamTopical | Pharmacy Value Alliance LLC | 68016-149 |
| GeriGentle FrostyHeat Pain Relief Patch Backmenthol | Menthol 50 mg/mL | PatchTopical | Geri-Gentle Corporation | 69771-012 |
| Lidocare Arm, Neck, Leg4% lidocaine | Lidocaine 11 mg/1 | PatchTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-450 |
| HealthWise Lidocaine Plus Menthol Patchlidocaine and menthol | Lidocaine 4 g/100g; Menthol 1 g/100g | PatchTopical | Veridian Healthcare | 71101-062 |
| Careland Plantar Fasciitis Hydrogel Pain Patcheslidocaine, menthol | Lidocaine 40 mg/g; Menthol 10 mg/g | PatchTopical | Planet (Anhui) Pharmaceutical Co., Ltd. | 75568-017 |
| Reinreude Back Pain Therapycamphor 80mg menthol 24mg capsicum extract 16mg back pain therapy | Capsicum 16 mg/1001 + 2 more ingredients | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-159 |
| Toast Screamin Hotcapsaicin | Capsaicin .1 g/100g | CreamTopical | IDEAZ, LLC | 78983-102 |
| PUREGEN LABS Pain Relief 4 Lidocainelidocaine | Lidocaine 40 mg/g | PatchTopical | Advanced Rx LLC | 80513-814 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skinhydrocortisone | Hydrocortisone .5 g/100g | CreamTopical | AmerisourceBergen | 24385-190 |
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