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
Extra Strength Itch Reliefdiphenhydramine hcl and zinc acetate	Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g	SprayTopical	Meijer Distribution Inc	79481-0598
3X Medicated Toothache and Gum Gelbenzocaine	Benzocaine 20 g/100g + 2 more ingredients	GelOral	Rite Aid	11822-0613
Meijer Pain Relieving Balm Analgesictrolamine salicylate	Trolamine salicylate 10 mg/g	CreamTopical	Meijer Distribution, Inc	41250-356
Ralli Rapid Pain Relief Roll onmenthol	Menthol 100 mg/mL	GelTopical	Troy Manufacturing, Inc.	63936-9527
CVS Health Pain Relievingcamphor (synthetic), menthol (unspecified form), methyl salicylate	Camphor (Synthetic) 28 mg/1 + 2 more ingredients	PatchTransdermal	Natural Essentials, Inc.	66902-280
Pbz Otctripelennamine hcl 1%	Tripelennamine 1 g/100g	CreamTopical	Kingsway Pharmaceuticals dba NFI, LLC	69993-151
Hydrocortisone	Hydrocortisone 1 g/100g	CreamTopical	Henry Schein	0404-0166
American Safety and First Aidhydrocortisone acetate	Hydrocortisone acetate 10 mg/g	CreamTopical	Orazen Inc	71927-015
MyDerm Bite Reliefbenzocaine	Benzocaine 5 g/100g	OintmentTopical	Inspec Solutions LLC.	72667-019
Thera Plus Maximum Strength Hydrocortisonehydrocortisone	Hydrocortisone 10 mg/g	CreamTopical	Fourstar Group USA, Inc	80684-197
Lidocaine 4%	Lidocaine 400 mg/10g	PatchTransdermal	Marcella Health	85096-201
Tough Love Pain Relievinglidocaine hcl	Lidocaine 4 g/100g	CreamTopical	Allure Labs	62742-4222
Stopain Extra Strength Gelmenthol	Menthol 80 mg/mL	GelTopical	Troy Manufacturing, Inc.	63936-9506
Fast Freeze Lidocaine Roll-Onlidocaine hydrochloride, benzyl alcohol	Lidocaine hydrochloride 40 mg/mL; Benzyl alcohol 10 mg/mL	LiquidTopical	Natural Essentials, Inc.	66902-235
Walgreens pain relievinglidocaine 4%	Lidocaine 4 g/100g	Aerosol, SprayTopical	Walgreens	0363-3038
Bikini Zone Medicated Cremelidocaine	Lidocaine 2 g/100g	CreamTopical	Kingsway Pharmaceuticals dba NFI, LLC	69993-043
American Safety First Aidlidocaine hcl	Lidocaine hydrochloride 20 mg/mL	SprayTopical	Orazen Inc	71927-012
ACOLYE Lidocaine Cream Topical Analgesia Creamlidocaine,menthol	Lidocaine 4 g/100g; Menthol 1 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-617
Healmusz Eczemahydrocortisone 1% eczema	Hydrocortisone 1 g/100g	CreamTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-203
ELAIMEI Numbing Creamlidocaine 4%	Lidocaine 4 g/100mL	CreamTopical	Shenzhen Shandian Jingling Technology Co., Ltd.	83804-005

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