Childrens Allergy
- Product NDC
- 69676-0074
- 11-digit product format
- 696760074
- Labeler code
- 69676
- Product ID
- 69676-0074_2ea022ca-e2ee-3856-e063-6294a90a484f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Genexa Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-04-26
- 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
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69676-0074-9 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69676-0074-9 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69676-0074-9 | 0efc9e666f02… | f202fb6c5f17… |
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
- Childrens Allergy
- Listing expiration
- 2026-12-31
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 |
|---|---|
| e880b8d7-61c3-41cc-e053-2995a90aaaeb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69676-0074-9 | 2025-02-26 | C162847 | 48780-1 | 2cef2736-a29d-d83d-e063-dadaa90ab31f | Children's Allergy |
| 69676-0074-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a29d-d83d-e063-dadaa90ab31f | Children's Allergy |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0074-9 | Childrens Allergy | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 69676-0074-9 | Childrens Allergy | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0074 | CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [GENEXA INC.] | 2 | Current NDC, 2 package rows | 20250228_e880b8d7-61c3-41cc-e053-2995a90aaaeb.zip |
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 |
|---|---|---|---|---|---|---|
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | bdc15c6f-73b4-488e-9134-e70565df71bb | 2026-01-14 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCL 50 MG | DIPHENHYDRAMINE HCL | YYBA Corporation | 4b012549-3958-43c1-9de7-897c5d8b20d3 | 2026-01-14 | Warnings | M012 |
| Rite Aid Pharmacy congestion relief vaporizing steam | VAPORIZING STEAM | Rite Aid Pharmacy | 0fb86b23-0313-8fd8-e063-6394a90a0f5f | 2026-01-14 | Warnings | M012 |
| Vapo Steam | VAPO STEAM | TOPCO ASSOCIATES, LLC | f216f69f-9580-25ac-e053-2995a90a5ac6 | 2026-01-14 | Warnings | M012 |
| Leader Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | f27bf0b2-25cc-474c-ab6b-f227ed3525fa | 2026-01-14 | Warnings | M012 |
| Sinus PE plus Allergy | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Walgreen Company | a15979d4-87bf-42e7-b1f2-783496072141 | 2026-01-13 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 41f4bf6d-f83c-92e4-e063-6394a90aebab | 2026-01-13 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e608643-1a74-b474-e063-6294a90ad2e0 | 2026-01-13 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | 4260542e-0980-4b0b-8177-1c9f2c53b5a6 | 2026-01-13 | Warnings | M012 |
| Sweet Comfort | MENTHOL | Saje Natural Business Inc. | cf13cccd-723d-4d61-8a5e-b36281605cc7 | 2026-01-13 | Warnings | M012 |
| Fortify | MENTHOL | Saje Natural Business Inc. | 0320a305-99d1-4909-94cc-cd6509ecb948 | 2026-01-13 | Warnings | M012 |
| Rolling Farmacy | MENTHOL | Saje Natural Business Inc. | a38765a9-22cd-4fc5-b5ab-c3cacbd52c74 | 2026-01-13 | Warnings | M012 |
| Home Farmacy | MENTHOL | Saje Natural Business Inc. | add35d10-b27a-4ae8-b2de-8a285aaef155 | 2026-01-13 | Warnings | M012 |
| Traveling Farmacy | MENTHOL | Saje Natural Business Inc. | 5b70f5aa-ed36-65ab-e053-2a91aa0a6777 | 2026-01-13 | Warnings | M012 |
| sinus plus allergy PE maximum strength | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 660d3c80-f249-41dd-aa93-a0b1e635ead0 | 2026-01-13 | Warnings | M012 |
| Chest Comfort | MENTHOL | Saje Natural Business Inc. | 8a3db169-6dd7-4dfd-8360-90315288f21b | 2026-01-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | H E B | c9e977b6-fba6-49ea-9d80-b43b0842bbe1 | 2026-01-12 | Warnings | M012 |
| PE Sinus Congestion | PHENYLEPHRINE HCL | Topco Associates, LLC | 3264e291-7a0f-4e25-8390-ba441f22f650 | 2026-01-12 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | 3f44cff6-240a-4a8d-aaa1-0da75a31a47b | 2026-01-12 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69676-0074-9 | 69676007409 | 1 BOTTLE, PLASTIC in 1 CARTON (69676-0074-9) / 118 mL in 1 BOTTLE, PLASTIC | 2022-04-26 | No | No | Current |