OTC - ACTIVE INGREDIENT SECTION
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
oral antiseptic
oral pain reliever
oral astringent
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this produt before. Stop use and seek immediate medical attention if you or a child in your care develops:
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other caine anesthetics.
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion Control Center right away.
Stop use and ask a doctor if
ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide
cut open tip of tube on score mark
adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor
children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product.
children under 2 years of age: do not use
Do not use:
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2370903 | benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream | PSN | 3 |
| 2370903 | benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral Cream | SCD | 3 |
| 2370903 | benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0011822020138 | GTIN-13: 0011822020138 EAN-13: 0011822020138 GTIN-12: 011822020138 UPC-A: 011822020138 GTIN storage (14 digits): 00011822020138 | 2821632R1 RA Nighttime Toothache and gum.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-6300-1 | Nighttime 4X Medicated Cream | 7 g in 1 TUBE | PASTE | 7 | 3 | |
| 11822-6300-1 | Nighttime 4X Medicated Cream | 1 in 1 CARTON | PASTE | 1 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11822-6300 | 11822-6300-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| CHAMOMILE | FGL3685T2X | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| SORBIC ACID | X045WJ989B | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
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 |
|---|---|---|---|---|---|---|
| Nighttime 4X Medicated Cream | BENZOCAINE | Rite Aid | 21645ed1-2dc0-223a-e063-6394a90ab021 | 2025-11-21 | Warnings | 11822-6300-1 11822-6300 11822630001 441ef5c1-674c-f57e-e063-6394a90ab336 21645ed1-2dc0-223a-e063-6394a90ab021 |
Adverse event summaries are temporarily unavailable. Other product information remains available.