ADWE dye-free childrens allergy
- Product NDC
- 68163-710
- 11-digit product format
- 681630710
- Labeler code
- 68163
- Product ID
- 68163-710_f8611e9e-6741-46f4-ac4d-612b50799110
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- RARITAN PHARMACEUTICALS INC
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-11-22
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- ADWE dye-free childrens allergy
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049906 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ea3a51af-3025-497f-8cd7-e99391b0d06f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68163-710-08 | ADWE dye-free childrens allergy | 1 in 1 CARTON | SYRUP | 1 | 5 | |
| 68163-710-08 | ADWE dye-free childrens allergy | 236 mL in 1 BOTTLE, PLASTIC | SYRUP | 236 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 40e73317-5126-4961-8f28-60899ffbec5a | 2024-02-20 | Warnings | M010 |
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 2424fb95-06e2-49e7-aea0-7797a37aef4d | 2024-02-20 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc | f5b609e1-e63b-2e3b-e053-2995a90a76b9 | 2024-02-12 | Warnings | M010 |
| Kroger Nighttime Sleep Aid CAPLET | DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | f0f3f58d-9457-4697-98e6-ef52d350cf67 | 2024-01-29 | Warnings | M010 |
| Nighttime Sleep Aid | NIGHTTIME SLEEP AID | Allegiant Health | 88feea1d-c961-45e9-b9a6-1418b970aaba | 2024-01-16 | Warnings | M010 |
| Sleep-Aid Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | 4283558d-62df-4297-bc85-a4e06681a920 | 2024-01-11 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | DeMoulas Market Basket | d3f35102-94ed-4da0-9c29-312e5468fa05 | 2023-12-29 | Warnings | M010 |
| nighttime sleep-aid | DIPHENHYDRAMINE HCL | Bionpharma Inc. | c0074c77-287e-6c26-e053-2995a90a4d31 | 2023-12-26 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYRAMINE HYDROCHLORIDE | TARGET CORPORATION | fac83dad-f6fd-3316-e053-6394a90a99aa | 2023-12-21 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENYDRAMINE HYDROCHLORIDE | TARGET CORPORATION | fc7ed67f-bac9-f9ed-e053-6294a90ad9a1 | 2023-12-16 | Warnings | M010 |
| Sleep-Aid, Circle K | DIPHENHYDRAMINE HCL CAPLET, 25MG | Lil' Drug Store Products, Inc. | d3ad24c4-44ba-6451-e053-2a95a90a1339 | 2023-12-14 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | VALU MERCHANDISERS COMPANY | fed2f7ae-2829-f967-e053-6294a90adc0a | 2023-10-12 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Better Living Brands LLC | 2b730fa5-47f9-468d-86ed-0d49d9cd8dc4 | 2023-07-06 | Warnings | M010 |
| Diphenhydramine HCl 25mg | SLEEP AID | Allegiant Health | 2890e4ba-d642-437d-8a86-24996a74e027 | 2021-11-23 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Allegiant Health | 9a0b347e-5719-42f3-9050-df5165495e88 | 2021-10-14 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Allegiant Health | ec57db48-0f3a-4b12-8633-b45a4366c269 | 2020-11-06 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | ea3a51af-3025-497f-8cd7-e99391b0d06f | 5 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | ea3a51af-3025-497f-8cd7-e99391b0d06f | 5 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | ea3a51af-3025-497f-8cd7-e99391b0d06f | 5 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | ea3a51af-3025-497f-8cd7-e99391b0d06f | 5 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | ea3a51af-3025-497f-8cd7-e99391b0d06f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68163-710-08 | 68163071008 | 1 BOTTLE, PLASTIC in 1 CARTON (68163-710-08) / 236 mL in 1 BOTTLE, PLASTIC | 2021-11-22 | 0000-00-00 | No | No | Current |