What is NDC 11383-192?

11383-192 is the product NDC for Bite and Itch, Pramoxine hydrochloride 1 g/100mL; Diphenhydramine hydrochloride 2 g/100mL lotion, listed with the FDA by Weeks & Leo Co., Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Bite and Itch (Diphenhydramine Hydrochloride, Pramoxine Hydrochloride).

What is the active ingredient?

Pramoxine hydrochloride, Diphenhydramine hydrochloride.

Weeks & Leo Co., Inc., NDC labeler code 11383. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bite and Itch?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bite and Itch NDC 11383-192 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11383-192Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11383-0192Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
11383-192-01	1138301920111383019201	1 BOTTLE in 1 CARTON (11383-192-01) / 118 mL in 1 BOTTLEMarketed from Jun 15, 2015
11383-192-04	1138301920411383019204	118 mL in 1 BOTTLE (11383-192-04)Marketed from Jun 15, 2015

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): Bite and Itch
Generic name (nonproprietary): diphenhydramine hydrochloride, pramoxine hydrochloride
Active ingredients: Pramoxine hydrochloride — 1 g/100mLDiphenhydramine hydrochloride — 2 g/100mL
Dosage form: Lotion
Route: Cutaneous
Labeler: Weeks & Leo Co., Inc.NDC labeler code 11383
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 017
Marketing start: Jun 15, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 11383-192_28650b5a-ed6f-199c-e063-6394a90a9dacSPL ID 28650b5a-ed6f-199c-e063-6394a90a9dacSPL set ID 0a4d471b-c3f3-0a6a-e063-6394a90ad57bRxCUI 1292321UNII 88AYB867L5, TC2D6JAD40
Pharmacologic class: Histamine-1 Receptor Antagonist

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N411383019201 followed by a unit qualifier and the quantity

Package 11383-0192-01. 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 Dec 3, 2024.

Indications (excerpt from the label)

Uses Temporarily relieves pain and itching due to: scrapes sunburn minor cuts minor burns insect bites minor skin irritations poison ivy, poison oak, or poison sumac

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11383-192

What is NDC 11383-192?: 11383-192 is the product NDC for Bite and Itch, Pramoxine hydrochloride 1 g/100mL; Diphenhydramine hydrochloride 2 g/100mL lotion, listed with the FDA by Weeks & Leo Co., Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bite and Itch (Diphenhydramine Hydrochloride, Pramoxine Hydrochloride).
What is the active ingredient?: Pramoxine hydrochloride, Diphenhydramine hydrochloride.
Who is the labeler?: Weeks & Leo Co., Inc., NDC labeler code 11383. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bite and Itch?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 017

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 017
Product	Strength	Form · route	Labeler	Product NDC
Stopain Extra Strength Continuousmenthol	Menthol 80 mg/mL	SprayTopical	Troy Manufacturing, Inc.	63936-4850
Fast Freeze Pain Relievingmenthol, unspecified form	Menthol, Unspecified form 33 mg/mL	GelTopical	NATURAL ESSENTIALS, INC.	66902-116
Walgreens Pain Reliefbenzocaine	Benzocaine 200 mg/g	GelOral	Walgreens Company	0363-5061
Blt 2lidocaine hcl	Lidocaine hydrochloride 4 g/100g	OintmentTopical	CENTURA PHARMACEUTICALS INC	70372-728
Lidocaine 4% Patchlidocaine 4%	Lidocaine 40 mg/g	PatchTopical	V2 Pharma, LLC	72835-400
Just Cbd Roll-On Coolingmenthol	Menthol 4 g/100mL	GelTopical	Just Brands LLC	73647-400
Magsoothium Body Cooling Formulamenthol	Menthol 5 g/100mL	CreamTopical	Ubu/Elements, Inc.	83262-002
Rapid Reliefpain relief patch camphor 110mg menthol 33mg capsicum extract 22mg	Levomenthol .3 g/100g + 2 more ingredients	PatchTopical	RAPID AID VIET NAM COMPANY LIMITED	83569-015
Terramed Just Think Comfort Hydrocortisone 1% Creamhydrocortisone	Hydrocortisone 10 mg/g	CreamTopical	Rida LLC	83004-051
Tktalker Numbingnumbing	Lidocaine 4 g/100g	CreamTopical	Shenzhen Shandian Jingling Technology Co., Ltd.	83804-113
Herb Street Backache and Sore Muscle Reliefmenthol	Menthol .1 g/g	StickTopical	Balassa Laboratories Inc.	10107-432
CBD Pain Relief Creamtrolamine salicylate	Trolamine salicylate 100 mg/g	CreamTopical	Allure Labs	62742-4198
3X Medicated Toothache and Gum Gelbenzocaine	Benzocaine 20 g/100g + 2 more ingredients	GelOral	Rite Aid	11822-0613
Hush Anestheticlidocaine	Lidocaine 40 mg/g	GelTopical	HUSH Anesthetic	49947-002
Jointivatrolamine salicylate 10%	Trolamine salicylate 10 g/100g	CreamTopical	Rising Pharma Holdings, Inc.	57237-355
Stopain Clinicalmenthol, unspecified form	Menthol, Unspecified form 100 mg/g	GelTopical	Troy Manufacturing, Inc.	63936-0975
Coralite Lidocaine 4% Flexible Pain Relief Patch 1ctlidocaine pain patch	Lidocaine 40 mg/g	PatchTopical	United Exchange Corp	65923-579
Desert Harvest RELEVEUMlidocaine	Lidocaine 40 mg/mL	CreamTopical	Desert Harvest Inc.	69145-201
A Health Itch Relief Gelitch relief gel	Diphenhydramine hydrochloride 2 mg/100mL	GelTopical	Bionpharma, Inc.	69452-496
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylatetrolamine salicylate	Trolamine salicylate 10 g/100g	CreamTopical	TELEBRANDS CORP	73287-032

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