Aveeno Baby Calming Comfort
- Product NDC
- 69968-0629
- 11-digit product format
- 699680629
- Labeler code
- 69968
- Product ID
- 69968-0629_21eb4c57-d7ff-d06c-e063-6394a90ae472
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Kenvue Brands LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-01
- Substance
- DIMETHICONE
- Active strength
- 12 mg/mL
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 69968-0629 | 69968-0629-8 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Aveeno Baby Calming Comfort
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 12 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 876980 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 567b1481-b783-45f9-af38-5630c9edf044 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69968-0629-1 | Aveeno Baby Calming Comfort | 532 mL in 1 BOTTLE, PUMP | LOTION | 532 | 5 | |
| 69968-0629-8 | Aveeno Baby Calming Comfort | 227 mL in 1 TUBE | LOTION | 227 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69968-0629 | AVEENO BABY CALMING COMFORT (DIMETHICONE) LOTION [KENVUE BRANDS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241103_567b1481-b783-45f9-af38-5630c9edf044.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 |
|---|---|---|---|---|---|---|
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 1ac59efd-9efd-09d9-e063-6394a90a5e40 | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | a3424b96-74b0-21c4-e053-2a95a90ae7ea | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | a4eb1cad-a9c0-43d3-e053-2995a90a06a0 | 2025-01-20 | Warnings | M016 |
| RICO Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | dc8ba3a2-9748-ec52-e053-2995a90a638b | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer | ALCOHOL | HANUL CO.,LTD | a4fa65f9-9786-76dd-e053-2995a90a6e13 | 2025-01-20 | Warnings | M016 |
| SAN Skinlab Cloth Wet Wipes | BENZALKONIUM CHLORIDE 0.13% | HANUL CO.,LTD | c058d278-3d6d-7e3c-e053-2995a90a6c2f | 2025-01-20 | Warnings | M016 |
| Rico Hand Sanitizer | ALCOHOL | HANUL CO.,LTD | a6065fcd-3968-d5a1-e053-2a95a90ab8d6 | 2025-01-20 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4465b-6e46-51e2-e063-6294a90a695f | 2025-01-16 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4a2b0-f586-3ab1-e063-6294a90aa1ed | 2025-01-16 | Warnings | M016 |
| Dermoia Manuka Honey Eczema | OATMEAL | TREASUREWISE LLC | 18c174de-6626-45ee-a6aa-f75a48daab8d | 2025-01-15 | Warnings | M016 |
| Allantoin | MEDICINAL MASSAGE OIL | Carolina Cannabis Creations L.L.C | 04b5619b-2122-f159-e063-6394a90a2e05 | 2025-01-15 | Warnings | M016 |
| Skin Barista 2in1 White Body Perfection | DIMETHICONE | Pioom Cosmetic Co.,ltd | 2d7fc20c-31a7-195b-e054-00144ff88e88 | 2025-01-15 | Warnings | M016 |
| Skin Barista Rice Bran Cleansing Foam | ALLANTOIN | Pioom Cosmetic Co.,ltd | 2d7fc7f6-1e89-116c-e054-00144ff8d46c | 2025-01-15 | Warnings | M016 |
| Hammertech Vitamin A and D | WHITE PETROLATUM | HAMMER TECH LLC | ffe96aa1-db6b-33e4-e053-6394a90a7e4e | 2025-01-14 | Warnings | M016 |
| NOON Cartessa Accelerate Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 400ead81-ab07-400f-b261-db330e0fd004 | 2025-01-14 | Warnings | M016 |
| NOON Post Procedure Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 9d1d11b4-40ff-4ea8-a3af-655f457c05f1 | 2025-01-14 | Warnings | M016 |
| OLP diaper Rash cream A and D | ZINC OXIDE | OL PHARMA TECH, LLC Drs PHARMACY | d6faa4d9-751c-a1b6-e053-2a95a90aee5b | 2025-01-09 | Warnings | M016 |
| ANTI-ITCH | ZINC ACETATE , DIPHENHYDRAMINE | OL PHARMA TECH, LLC | b79d3096-c609-e710-e053-2995a90a8da2 | 2025-01-09 | Warnings | M016 |
| ANTIBACTERIAL DREAMY FLORALS | GLYCERIN | Quimicas Handal de Centroamerica SA de CV | 09f73bec-516d-90f0-e063-6394a90aecab | 2025-01-08 | Warnings | M016 |
| AOAO Repair Foot Cream | UREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL. | Guangdong Junhui Biotechnology Co.,LTD | 21064e84-c827-ca82-e063-6394a90a6c65 | 2025-01-08 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 876980 | dimethicone 1.2 % Topical Lotion | PSN | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
| 876980 | dimethicone 12 MG/ML Topical Lotion | SCD | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
| 876980 | dimethicone 1.2 % Topical Lotion | SY | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69968-0629-1 | 69968062901 | 532 mL in 1 BOTTLE, PUMP (69968-0629-1) | 532 ml | 2020-06-01 | 0000-00-00 | No | No | Current |
| 69968-0629-8 | 69968062908 | 227 mL in 1 TUBE | 227 ml | Historical |